Accommodating intraocular lens and methods of implantation

ABSTRACT

An accommodating intraocular lens device for treatment of an eye having a lens body; internal support; stabilization system; and force translation arm. The lens body includes an accommodating membrane, an annular element, a static element, and a fixed volume of optical fluid filling a sealed chamber of the lens body. The annular element coupled to the perimeter of the accommodating membrane has a shape deformation membrane configured to undergo displacement relative to the perimeter region. The sealed chamber is formed by inner surfaces of the accommodating membrane, shape deformation membrane, and static element. The force translation arm has a first end operatively coupled to the shape deformation membrane and a free end available and configured to engage a ciliary structure of the eye. The force translation arm is moveable relative to the lens body to cause inward movement of the shape deformation membrane. Related methods, devices, and systems are provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.16/345,364, filed Apr. 26, 2019, which is a 371 U.S. National PhaseApplication of PCT Application Serial No. PCT/US2017/58810, filed onOct. 27, 2017, which claims the benefit of priority to U.S. ProvisionalApplication Ser. No. 62/414,571, filed Oct. 28, 2016, the entirecontents of which are hereby incorporated by reference herein in theirentireties.

BACKGROUND

The present disclosure relates generally to the field of ophthalmics,more particularly to ophthalmic devices, including intraocular lenses(IOLs) such as accommodating intraocular lenses.

A healthy, young human eye can focus an object in far or near distance,as required. The capability of the eye to change back and forth fromnear vision to far vision is called accommodation. Accommodation occurswhen the ciliary muscle contracts to thereby release the resting zonulartension on the equatorial region of the capsular bag. The release ofzonular tension allows the inherent elasticity of the lens to alter to amore globular or spherical shape, with increased surface curvatures ofboth the anterior and posterior lenticular surfaces.

The human lens can be afflicted with one or more disorders that degradeits functioning in the vision system. A common lens disorder is acataract which is the opacification of the normally clear, naturalcrystalline lens matrix. The opacification can result from the agingprocess but can also be caused by heredity or diabetes. In a cataractprocedure, the patient's opaque crystalline lens is replaced with aclear lens implant or IOL.

In conventional extracapsular cataract surgery, the crystalline lensmatrix is removed leaving intact the thin walls of the anterior andposterior capsules together with zonular ligament connections to theciliary body and ciliary muscles. The crystalline lens core is removedby phacoemulsification through a curvilinear capsulorhexis i.e., theremoval of an anterior portion of the capsular sac.

After a healing period of a few days to weeks, the capsular saceffectively shrink-wraps around the IOL due to the collapse of the wallsof the capsular sac and subsequent fibrosis. Cataract surgery aspracticed today causes the irretrievable loss of most of the eye'snatural structures that provide accommodation. The crystalline lensmatrix is completely lost and the integrity of the capsular sac isreduced by the capsulorhexis. The “shrink-wrap” of the capsular sacaround the IOL can damage the zonule complex, and thereafter the ciliarymuscles may atrophy. Thus, conventional IOL's, even those that professto be accommodative, may be unable to provide sufficient axial lensspatial displacement along the optical axis or lens shape change toprovide an adequate amount of accommodation for near vision.

Beyond IOL placement following cataract surgery, it is known that anartificial, “piggy back,” lens can be utilized to correct the refractiveerror of a healthy crystalline lens. Additionally, this “piggy back”approach can be beneficial to a patient who has previously undergonecataract surgery, has an artificial lens in place, but needs additionalrefractive correction. These “piggyback” IOLs can be placed anterior tothe previously implanted IOL or natural lens to improve the refractiveresults of cataract surgery in the case of pseudophakes or to change therefractive status of the eye in the case of phakic eyes, usually tocorrect high myopia. Generally, these lenses are implanted in the sulcusor angle and are non-accommodating.

SUMMARY

In an aspect, described is an accommodating intraocular lens device fortreatment of an eye including a lens body having an accommodatingmembrane with a perimeter region and a surface configured to outwardlybow. The lens body has an annular element is coupled to the perimeter ofthe accommodating membrane. The annular element has a shape deformationmembrane extending along an arc of the annular element. The shapedeformation membrane is configured to undergo displacement relative tothe perimeter region of the accommodating membrane. The lens body has astatic element having a perimeter region coupled to the annular element.The static element is positioned opposite the accommodating membrane.The lens body has a fixed volume of optical fluid. An inner surface ofthe accommodating membrane, an inner surface of the shape deformationmembrane and an inner surface of the static element collectively form asealed chamber of the lens body filled by the fixed volume of opticalfluid. An annular, internal support is sealed with the perimeter regionof the accommodating membrane on a first side and sealed with theperimeter region of the static element on a second side. A stabilizationsystem includes a haptic having an internal portion and a terminal end.The internal portion of the haptic is coupled to the annular internalsupport near the perimeter region of the lens body. A force translationarm is included that has a first end operatively coupled to the shapedeformation membrane of the lens body and a free end available andconfigured to engage a ciliary structure of the eye when the lens deviceis implanted in the eye such that an optical axis of the lens body issubstantially aligned with a visual axis of the eye. The forcetranslation arm is movable relative to the lens body to cause inwardmovement of the shape deformation membrane.

Inward movement of the force translation arm can cause the inwardmovement of the shape deformation membrane and a deformation of thesealed chamber. Inward movement of the shape deformation membrane cancause the optical fluid in the sealed chamber to press against the innersurface of the accommodating membrane. The internal support canmechanically isolate optical components of the lens body from distortionduring movement of the force translation arm relative to the lens bodyand from distortion due to stresses on the stabilization system. Anouter perimeter of the internal support can include a concave geometryto avoid contact with the inner surface of the shape deformationmembrane during inward movement of the shape deformation membrane. Anouter perimeter of the internal support can include features having awedge shape that tapers toward a central aperture of the annular,internal support. The internal support can form a partition within thesealed chamber dividing the sealed chamber into a deformable region anda central region. The internal support can include a channel extendingthrough the internal support providing fluid communication between thedeformable region and the central region of the sealed chamber. Thedeformable region can be located outside an optic zone of the lens bodyor inside an optic zone of the lens body. Inward movement of the shapedeformation membrane can deform the deformable region. Inward movementof the shape deformation membrane can compress the sealed chamber. Theoptical fluid in the sealed chamber can be non-compressible and pressagainst the inner surface of the accommodating membrane to cause theoutward bowing of the accommodating membrane upon inward movement of theshape deformation member. The shape deformation membrane can move adistance of between about 50 μm to about 100 μm. Movement of the shapedeformation membrane can cause a change in power of the lens body by atleast ±3 diopters. A force applied to move the shape deformationmembrane can be between about 0.1 gf to about 1 gf.

The terminal end of the haptic can further include a biting element toimprove fixation of the haptic within the eye. The biting element caninclude a grooved edge and/or a hole. The terminal end of the haptic canextend over the force translation arm. The terminal end of the hapticcan be positioned on a different plane than the force translation arm.The terminal end of the haptic can extend on a plane anterior to theforce translation arm and can be configured to be positioned within aciliary sulcus or the capsular bag of the eye. The haptic can beflexible, foldable or formed of a shape memory material. The lens bodycan include a deformable portion that is located outside an optic zone.The deformable portion can be a region of the shape deformationmembrane. The lens body can include a deformable portion that is locatedinside an optic zone. The deformable portion can be a region of theshape deformation membrane. The shape deformation membrane can beannular. The outward bowing of the shape changing membrane can bemanually adjustable. The static element can be a static lens having anoptical power. The static lens can be positioned posteriorly relative tothe eye and the shape changing member can be positioned anteriorlyrelative to the eye. The shape changing membrane can have a constantthickness. The region of the shape changing membrane can be a reducedthickness region prone to give way upon increased internal pressurewithin the sealed chamber or upon application of pressure by the opticalfluid against the inner surface of the shape changing membrane.

The optical fluid can include a non-compressible liquid or gel of highclarity and transmission in the visible spectrum. The optical fluid canbe silicone oil or fluorosilicone oil. The force translation arm canhave a length configured to extend between the shape deformationmembrane of the lens body and the ciliary structure. The length can beadjustable during insertion of the device in the eye. The adjustment canbe mechanical or due to rotation of the device relative to the eye. Aperimeter of the device can have a maximum cross-sectional thicknesssized to extend between a posterior region of the iris and an anteriorregion of the capsular bag.

In an interrelated aspect, provided is an accommodating intraocular lensdevice for treatment of an eye having a lens body. The lens bodyincluding an accommodating membrane having a perimeter region andsurface configured to outwardly bow. An annular element is coupled tothe perimeter of the accommodating membrane. The annular element has ashape deformation membrane extending along an arc of the annularelement. The shape deformation membrane is configured to undergodisplacement relative to the perimeter region of the accommodatingmembrane. The device includes a static element having a perimeter regioncoupled to the annular element. The static element is positionedopposite the accommodating membrane. The device includes a fixed volumeof optical fluid. An inner surface of the accommodating membrane, aninner surface of the shape deformation membrane and an inner surface ofthe static element collectively form a sealed chamber of the lens bodyfilled by the fixed volume of optical fluid. The device includes anannular internal support sealed with the perimeter region of theaccommodating membrane on a first side and sealed with the perimeterregion of the static element on a second side. The device includes astabilization system includes an annular ring structure coupled to theannular internal support and a flange extending radially outward from aposterior region of the lens body. The device includes a forcetranslation arm having a first end operatively coupled to the shapedeformation membrane of the lens body and a free end available andconfigured to engage a ciliary structure of the eye when the lens deviceis implanted in the eye such that an optical axis of the lens body issubstantially aligned with a visual axis of the eye. The forcetranslation arm is movable relative to the lens body to cause inwardmovement of the shape deformation membrane.

Inward movement of the force translation arm can cause the inwardmovement of the shape deformation membrane causing a deformation of thesealed chamber. Inward movement of the shape deformation membrane cancause the optical fluid in the sealed chamber to press against the innersurface of the accommodating membrane. The internal support canmechanically isolate optical components of the lens body from distortionduring movement of the force translation arm relative to the lens bodyand from distortion due to stresses on the stabilization system. Anouter perimeter of the internal support can include a concave geometryto avoid contact with the inner surface of the shape deformationmembrane during inward movement of the shape deformation membrane. Anouter perimeter of the internal support can include features having awedge shape that tapers toward a central aperture of the annular,internal support. The internal support can form a partition within thesealed chamber dividing the sealed chamber into a deformable region anda central region. The internal support can include a channel extendingthrough the internal support providing fluid communication between thedeformable region and the central region of the sealed chamber. Thedeformable region can be located outside an optic zone of the lens body.The deformable region can be located inside an optic zone of the lensbody. Inward movement of the shape deformation membrane can deform thedeformable region. Inward movement of the shape deformation membrane cancompress the sealed chamber. The optical fluid in the sealed chamber canbe non-compressible and press against the inner surface of theaccommodating membrane to cause the outward bowing of the accommodatingmembrane upon inward movement of the shape deformation member. The shapedeformation membrane can move a distance between about 50 μm to about100 μm. Movement of the shape deformation membrane can cause a change inpower of the lens body by at least ±3 diopters. A force applied to movethe shape deformation membrane can be between about 0.1 gf to about 1gf.

The flange extending radially outward can be positioned a distance awayfrom the force translation arm. The flange can be positioned in aposterior position relative to the lens body and to the forcetranslation arm. The anterior surface of the flange may also be on thesame plane as the force translation arm. The more anterior the flange,the greater it will pull the lens in a posterior direction. The forcetranslation arm can include first and second force translation armspositioned opposite each other. The flange can include first and secondflanges positioned opposite each other. The first and second flanges canbe positioned between the first and second force translation arms. Thestabilization system can further include a groove located near theannular ring structure. The groove can be formed between aposterior-facing surface of the annular element and an anterior-facingsurface of the flange. The groove can be sized to receive a capsular bagedge formed by a capsulorhexis in the capsular bag. The flange caninclude an outer elevation bending toward an anterior direction. Theflange can further include an interruption configured to provide accessto the capsular bag. The interruption can be an aperture extendingthrough the flange or an indentation in an outer perimeter of theflange.

The lens body can include a deformable portion that is located outsidean optic zone. The deformable portion can be a region of the shapedeformation membrane. The lens body can include a deformable portionthat is located inside an optic zone. The deformable portion can be aregion of the shape deformation membrane. The shape deformation membranecan be annular. Outward bowing of the shape changing membrane can bemanually adjustable after implantation of the device in the eye. Thestatic element can be a static lens having an optical power. The staticlens can be positioned posteriorly relative to the eye and the shapechanging member can be positioned anteriorly relative to the eye. Theshape changing membrane can have a constant thickness. The region of theshape changing membrane can be a reduced thickness region prone to giveway upon increased internal pressure within the sealed chamber or uponapplication of pressure by the optical fluid against the inner surfaceof the shape changing membrane. The optical fluid can include anon-compressible liquid or gel of high clarity and transmission in thevisible spectrum. The optical fluid can be silicone oil orfluorosilicone oil. The force translation arm can have a lengthconfigured to extend between the shape deformation membrane of the lensbody and the ciliary structure. The length can be adjustable duringinsertion of the device in the eye. The adjustment can be mechanical ordue to rotation of the device relative to the eye. A perimeter of thedevice can have a maximum cross-sectional thickness sized to extendbetween a posterior region of the iris and an anterior region of thecapsular bag. Asymmetric inward movement of the force translation armrelative to the lens body can achieve a spherical outward bowing of thesurface of the accommodating membrane. The device can include a singlefirst translation arm or can further include a second force translationarm. The first and second force translation arms can be positionedopposite to one another and symmetrically relative to the lens body.

In an interrelated aspect, described is a method of implanting anaccommodating intraocular lens (AIOL) device for treatment of an eye.The method includes forming a capsulorhexis; and implanting an AIOLdevice.

The AIOL device can include a lens body. The lens body can include anaccommodating membrane having a perimeter region and surface configuredto outwardly bow. The lens body can include an annular element coupledto the perimeter of the accommodating membrane. The annular element hasa shape deformation membrane extending along an arc of the annularelement. The shape deformation membrane is configured to undergodisplacement relative to the perimeter region of the accommodatingmembrane. The lens body can include a static element having a perimeterregion coupled to the annular element. The static element is positionedopposite the accommodating membrane. The lens body can include a fixedvolume of optical fluid. An inner surface of the accommodating membrane,an inner surface of the shape deformation membrane and an inner surfaceof the static element can collectively form a sealed chamber of the lensbody filled by the fixed volume of optical fluid. The device can includean annular internal support sealed with the perimeter region of theaccommodating membrane on a first side and sealed with the perimeterregion of the static element on a second side. The device can include astabilization system. The device can include a force translation armhaving a first end operatively coupled to the shape deformation membraneof the lens body and a free end available and configured to engage aciliary structure of the eye when the lens device is implanted in theeye such that an optical axis of the lens body is substantially alignedwith a visual axis of the eye. The force translation arm is movablerelative to the lens body to cause inward movement of the shapedeformation membrane.

The stabilization system can include an annular ring structure coupledto the annular internal support and a flange extending radially outwardfrom a posterior region of the lens body. The stabilization system caninclude stabilization haptics having an internal portion and a terminalend, the internal portion of the haptic coupled to the annular internalsupport near the perimeter region of the lens body. The device caninclude two, opposing force translation arms.

The method can further include positioning the stabilization hapticswithin the ciliary sulcus to urge the device posteriorly away from theiris of the eye. The method can further include positioning thestabilization haptics inside a capsular bag of the eye and implantingthe force translation arms outside the capsular bag. The method canfurther include extending edges of the capsular bag formed by thecapsulorhexis over an anterior surface of the stabilization haptics. Ananterior face of the device can be pulled away from the iris of the eyeby the edges of the capsular bag. The method can further includeorienting the device upon implantation such that a posterior surface ofthe device is positioned posterior to the capsulorhexis and the forcetranslation arms remain anterior to the capsulorhexis. Orienting thedevice can include orienting the opposing force translation armshorizontally in a medio-lateral manner relative to the eye to minimizeshifting following implantation. Implanting the device can includerotating the device around its optical axis. The method can furtherinclude rotating the device around its optical axis, but maintaining agap between an outermost portion of the force translation arm and theciliary structure. The gap can have a size of about 0.1 mm. The methodcan further include rotating the device around its optical axis until anoutermost portion of the force translation arm wedges into engagementwith the ciliary structure. The ciliary structure can be the ciliarymuscle of the eye. Rotating the device can adjust a fit of the forcetranslation arm relative to the ciliary muscle. The device can beimplanted by inserting the device through a corneal incision in the eye.The method can further include rolling or folding the device into anapplicator and injected through the corneal incision. A tip of theapplicator can be about 2.5 mm in cross-sectional diameter. The devicecan be implanted by inserting the device through a scleral tunnel or ascleral incision. The capsulorhexis can be oval shaped. Thecapsulorhexis can be about 6 mm×7 mm. The method can further includemeasuring a diameter of the ciliary body of the eye prior to implantingthe AIOL device. The diameter can be measured by ultrasoundbiomicroscopy (UBM), optical coherence tomography (OCT), or othermedical imaging techniques.

In some variations, one or more of the following can optionally beincluded in any feasible combination in the above methods, apparatus,devices, and systems. More details of the devices, systems, and methodsare set forth in the accompanying drawings and the description below.Other features and advantages are apparent from the followingdescription and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects will now be described in detail with referenceto the following drawings. Generally speaking the figures are not toscale in absolute terms or comparatively but are intended to beillustrative. Also, relative placement of features and elements may bemodified for the purpose of illustrative clarity.

FIG. 1A is a perspective cut-away view of an eye with an opacified lenscapsule;

FIG. 1B is a perspective cut-away view of the eye of FIG. 1A with acurvilinear capsulorhexis and the crystalline lens matrix removed withthe implantation of a traditional 3-piece IOL;

FIG. 1C is a cross-sectional view of an anterior angle of an eye;

FIG. 2A is a perspective view of an implementation of an accommodatingintraocular lens (“AIOL”);

FIG. 2B is an exploded view of the AIOL of FIG. 2A;

FIG. 2C is a first side view of the AIOL of FIG. 2B;

FIG. 2D is a second side view of the AIOL of FIG. 2B;

FIG. 2E is a cross-sectional view of the AIOL of FIG. 2D taken alongline E-E;

FIG. 2F is a cross-sectional view of the AIOL of FIG. 2A taken alongline F-F;

FIGS. 3A-3B are perspective views of an anterior lens portion of theAIOL of FIG. 2A;

FIG. 3C is a cross-sectional view of the anterior lens portion of FIG.3B taken along line C-C;

FIGS. 3D-3G are schematic views of anterior lens portions of variousimplementations of an AIOL;

FIGS. 4A-4C illustrate an accommodating intraocular lens positionedwithin the eye relative to the iris and the capsular bag;

FIGS. 5A-5B are cross-sectional, partial perspective views of anaccommodating intraocular lens device positioned within the eye;

FIG. 6A is an anterior view of the eye showing an oval capsulorhexis;

FIG. 6B is an anterior view of the eye in FIG. 6A showing anaccommodating intraocular lens device positioned within the eye with theiris hidden;

FIG. 7A is a perspective anterior view of an accommodating intraocularlens device having a stabilization system;

FIG. 7B is a side elevational view of the lens device of FIG. 7A;

FIG. 7C is a perspective posterior view of the lens device of FIG. 7A;

FIG. 7D is a perspective anterior view of a lens device incorporatingprongs on an outer portion of the force translation arms;

FIG. 8 is a flowchart illustrating an implementation of a method forlens selection;

FIG. 9 is a flowchart illustrating an implementation of a method forintraoperative lens adjustment;

FIG. 10 is a flowchart illustrating an implementation of a method forpost-operative lens adjustment;

FIGS. 11A-11B illustrate a top plan view and a side elevational view,respectively, of an implementation of a lens having a plurality ofvisualization markers;

FIGS. 11C-11D illustrate a top plan view and a side elevational view,respectively, of an implementation of a lens having a plurality ofvisualization markers;

FIGS. 11E-11L illustrate top plan and side elevational views of variousconfigurations of visualization markers;

FIG. 12 illustrates a cross-sectional, partial perspective view of anaccommodating intraocular lens device positioned within the eye andhaving a stabilization system preventing contact between the capsularbag and the shape deformation membrane;

FIG. 13A illustrates a top view of an accommodating intraocular lensdevice;

FIG. 13B illustrates a cross-sectional, partial view of the device ofFIG. 13A taken along section A-A;

FIG. 13C illustrates another implementation of a cross-sectional,partial view of the device of FIG. 13A taken along section A-A;

FIG. 14A illustrates a perspective view of an implementation of anaccommodating intraocular lens device;

FIGS. 14B-14C illustrate a top plan view and a bottom plan view,respectively, of the device of FIG. 14A;

FIGS. 14D-14E illustrate side elevational views of the device of FIG.14A;

FIG. 14F illustrates a cross-sectional view of the device of FIG. 14Btaken along line F-F;

FIG. 14G illustrates a cross-sectional side view of the device of FIG.14B taken along line G-G;

FIG. 14H illustrates an exploded, perspective view of the device of FIG.14A;

FIG. 14I illustrates a cross-sectional, perspective view of animplementation of a stabilization system;

FIG. 15A illustrates a perspective view of an implementation of anaccommodating intraocular lens device having a stabilization system;

FIG. 15B is a cross-sectional view taken along line B-B of FIG. 15A;

FIG. 15C is the stabilization system of the device of FIG. 15A;

FIG. 16A illustrates a perspective view of an implementation of anaccommodating intraocular lens device having a stabilization system;

FIG. 16B is a cross-sectional view taken along line B-B of FIG. 16A;

FIG. 16C is a cross-sectional view taken along line C-C of FIG. 16A;

FIG. 16D is the internal support and stabilization system of the deviceof FIG. 16A;

FIGS. 16E-16F are side views of the device of FIG. 16A;

FIG. 17A illustrates a perspective view of an implementation of anaccommodating intraocular lens device having a stabilization system;

FIG. 17B is a cross-sectional view taken along line B-B of FIG. 17A;

FIG. 17C is a cross-sectional view taken along line C-C of FIG. 17A;

FIG. 17D is the internal support of the device of FIG. 17A;

FIGS. 17E-17F are side views of the device of FIG. 17A;

FIG. 18A illustrates a perspective view of an implementation of anaccommodating intraocular lens device;

FIG. 18B is a top view of the device of FIG. 18A;

FIG. 18C is a cross-sectional view taken along line C-C of FIG. 18A;

FIG. 19A illustrates a top view of an implementation of an accommodatingintraocular lens device having a stabilization system;

FIG. 19B illustrates a top view of an implementation of an accommodatingintraocular lens device having a stabilization system;

FIG. 19C illustrates a perspective view of the device of FIG. 19B;

FIG. 19D is a cross-sectional view taken along line D-D of FIG. 19C;

FIG. 19E is the internal support of the device of FIG. 19B supporting aposterior optic.

It should be appreciated that the drawings herein are exemplary only andare not meant to be to scale.

DETAILED DESCRIPTION

The present disclosure relates generally to the field of ophthalmics,more particularly to ophthalmic devices, including intraocular lenses(IOLs) such as accommodating intraocular lenses (AIOLs). The dynamicnature of AIOLs allows for a large, continuous range of focusing power,just as in a young accommodative natural eye. The devices describedherein can provide focusing power across the full accommodative rangefrom distance to near by mechanically and functionally interacting witheye tissues typically used by a natural lens such as the ciliary body,ciliary processes, and the zonules, to effect accommodation anddisaccommodation. The forces generated by these tissues are functionallytranslated to the devices described herein causing a power change tomore effectively accommodate. The devices described herein areconfigured to be adjusted for size and fit prior to, during, as well asat any time after implantation. The devices described herein can beimplanted in the eye to replace a diseased, natural lens. It should beappreciated, however, the devices can also be implanted as a supplementof a natural lens (phakic patient) or an intraocular lens previouslyimplanted within a patient's capsular bag (pseudophakic patient).

With reference to FIGS. 1A and 1C, the human eye 10 includes a cornea12, iris 14, sulcus 16, ciliary muscle 18, zonules 20, a lens 21contained within a capsular bag 22. Accommodation occurs when theciliary muscle 18 contracts to thereby release the resting zonulartension on the equatorial region of the capsular bag 22. The release ofzonular tension allows the inherent elasticity of the lens 21 to alterto a more globular or spherical shape, with increased surface curvaturesof both the anterior lenticular surface 23 and posterior lenticularsurface 24. In addition, the human lens can be afflicted with one ormore disorders that degrade its functioning in the vision system. Acommon lens disorder is a cataract which consists of the opacificationof the normally clear, natural crystalline lens matrix 26. Theopacification can result from the aging process but can also be causedby heredity, diabetes, or trauma. FIG. 1A shows a lens capsulecomprising a capsular bag 22 with an opacified, crystalline lens nucleus26.

In a cataract procedure, the patient's opaque crystalline lens isreplaced with a clear lens implant or IOL 30. In conventionalextracapsular cataract surgery as depicted in FIG. 1B, the crystallinelens matrix 26 is removed leaving intact the thin walls of the anteriorand posterior capsules together with zonular ligament connections to theciliary body and ciliary muscles 18. The crystalline lens core isremoved by phacoemulsification through a curvilinear capsulorhexis asillustrated in FIG. 1B, i.e., the removal of an anterior portion 23 ofthe capsular sac. FIG. 1B depicts a conventional 3-piece IOL 30 justafter implantation in the capsular bag 22. The capsular bag 22 after ahealing period of a few days to weeks can effectively shrink-wrap arounda conventional 3-piece IOL 30 due to the collapse of the walls of thesac 22 and subsequent fibrosis. Cataract surgery as practiced todaycauses the irretrievable loss of most of the eye's natural structuresthat provide accommodation. The crystalline lens matrix 26 is completelylost and the integrity of the capsular sac 22 is reduced by thecapsulorhexis. The fibrosis of the capsular bag limits the dynamicmovement of a lens placed in that bag. Thus, conventional IOL's, eventhose that profess to be accommodative, may be unable to providesufficient axial lens spatial displacement along the optical axis orlens shape change to provide an adequate amount of accommodation fornear vision.

It is known to implant a combination of lenses to address refractionerrors in the existing lens in the case of phakic IOLs or improve therefractive results of standard IOL after cataract surgery in the case ofpseudophakic patients. These “piggyback” IOLs can be placed anterior tothe previously implanted IOL or natural lens to improve the refractiveresults of cataract surgery in the case of pseudophakes or to change therefractive status of the eye in the case of phakic eyes, usually tocorrect high myopia. Generally, these lenses are implanted in theciliary sulcus and are non-accommodating. As best shown in FIG. 1C, theciliary sulcus 16 is the space between the posterior surface of the baseof the iris 14 and the anterior surface of the ciliary body.

Accommodating IOLs are also beneficial for patients not suffering fromcataracts, but who wish to reduce their dependency on glasses andcontacts to correct their myopia, hyperopia and presbyopia. Intraocularlenses used to correct large errors in myopic, hyperopic, and astigmaticeye are called “phakic intraocular lenses” and are implanted withoutremoving the crystalline lens. In some cases, aphakic IOLs (not phakicIOLs) are implanted via lens extraction and replacement surgery even ifno cataract exists. During this surgery, the crystalline lens isextracted and an IOL replaces it in a process that is very similar tocataract surgery. Refractive lens exchange, like cataract surgery,involves lens replacement, requires making a small incision in the eyefor lens insertion, use of local anesthesia and lasts approximately 30minutes. The accommodating IOLs described herein can be used in patientsfor refractive lens exchange.

Described herein are accommodating IOLs (“AIOLs”) that can achieve thedesired optical power change, for example in the range of 1 diopter (1D) to 3 D up to about 5 D or 6 D. As will be described in more detailbelow, the devices described herein can include an accommodativemechanism including one or more force translation arms configured to bepositioned in the eye such that they harness movements of one or moreciliary structures and translate the movements into functional forces todrive shape change of the lens body for accommodation anddisaccommodation in a manner independent of capsular bag movements. Thedevices described herein can further include a stabilization systemseparate from the accommodative mechanism that is configured to bepositioned, for example, within the capsular bag. The devices describedherein obviate known issues that tend to occur due to capsular fibrosisdescribed above. It should be appreciated that the devices describedherein can be configured to harness movements of one or combinations ofciliary structures including, but not limited to, the ciliary muscle,the ciliary body, ciliary processes, and zonules. For the sake ofbrevity, the term “ciliary structure” may be used herein to refer to anyof the one or more ciliary structures for which movements can beharnessed by the force translation arms to effect accommodation of thelens body.

The devices described herein can be implanted in the eye to replace adiseased, natural lens. In some implementations, the devices describedherein can be implanted as aphakic IOLs via refractive lens exchangeprocedures. The intraocular lenses described herein can also beimplanted as a supplement of a natural lens (phakic patient) or anintraocular lens previously implanted within a patient's capsular bag(pseudophakic patient). The lenses described herein can be used incombination with intraocular lenses described in U.S. Patent PublicationNos. 2009/0234449, 2009/0292355, 2012/0253459, and PCT Publication No.WO 2015/148673, which are each incorporated by reference herein in theirentirety. As such, the lenses described herein can be used independentlyor as so-called “piggyback” lenses. Piggyback lenses can be used tocorrect residual refractive errors in phakic or pseudophakic eyes. Theprimary IOL used to replace the natural lens is generally thicker andusually has a power that can be in the range of ±10 D to ±25 D. Thethicker, larger power lenses generally do not accommodate. In contrast,the supplemental lens need not provide significant optical power to thesystem. The supplemental lens can be relatively thin compared to theprimary IOL and can undergo more accommodation. Shape change andmovement of the thinner lens is generally more easily accomplishedrelative to a thick primary lens. The AIOLs described herein can be usedindependently and need not be used in combination as piggyback lenseswith the natural lens or an implanted IOL. One or more components of theAIOLs described herein can be configured to be positioned in the sulcus16, against the ciliary processes, within the capsular bag 22 or acombination thereof.

Turning now to FIGS. 2A to 2F, the accommodating intraocular lens(“AIOL”) 100 can include a lens body 105 and one or more forcetranslation arms 115, each of which will be described in more detailbelow. As will be described in more detail below, the force translationarms 115 are configured to harness movements of one or more of theciliary structures such that they are bi-directionally movable relativeto the lens body 105 to effect accommodative shape change of the lensbody 105. For example, and without limiting this disclosure to anyparticular theory or mode of operation, the ciliary muscle 18 is asubstantially annular structure or sphincter. In natural circumstances,when the eye is viewing an object at a far distance, the ciliary muscle18 within the ciliary body relaxes and the inside diameter of theciliary muscle 18 gets larger. The ciliary processes pull on the zonules20, which in turn pull on the lens capsule 22 around its equator. Thiscauses a natural lens to flatten or to become less convex, which iscalled disaccommodation. During accommodation, the ciliary muscle 18contracts and the inside diameter of the ring formed by the (ciliaryring diameter, CRD) ciliary muscle 18 gets smaller. The ciliaryprocesses release the tension on the zonules 20 such that a natural lenswill spring back into its natural, more convex shape and the eye canfocus at near distances. This inward/anterior movement of the ciliarymuscle 18 (or one or more ciliary structures) can be harnessed by theforce translation arms 115 to cause a shape change in the lens body 105.

Still with respect to FIGS. 2A to 2F, the lens body 105 can include agenerally ring-shaped perimeter region or annular element 104, ananterior optic 145, a static element 150, and a fixed volume, sealedchamber 155 filled by a fixed volume of an optical fluid 156. Theannular element 104 can include an anterior end region, a posterior endregion 107, and an intervening equator region 108. The anterior endregion of the annular element 104 can be coupled to the anterior optic145 and the posterior end region of the annular element 104 can becoupled to the static element 150 such that the anterior optic 145 ispositioned opposite the static element 150. FIGS. 3A-3B also illustratethe posterior end region 107 and the equator region 108 of annularelement 104. The anterior optic 145 of the lens body 105 can include acentral, dynamic membrane 143 surrounded by a perimeter region 144. Theperimeter region 144 can be coupled to or integral with the annularelement 104 of the lens body 105. The dynamic membrane 143 of theanterior optic 145 is configured to undergo a shape change whereas theperimeter region 144 can be configured to resist or not to undergo ashape change. The static element 150, which can be a static lens, maynot undergo a shape change as well.

The terms “anterior” and “posterior” as used herein are used to denote arelative frame of reference, position, direction or orientation forunderstanding and clarity. Use of the terms is not intended to belimiting to the structure and/or implantation of the lens. For example,the orientation of the lens body 105 within the eye can vary such thatthe anterior optic 145 can be positioned anteriorly along the opticalaxis A of the AIOL 100 and the static element 150 positioned posteriorlyalong the optical axis A of the AIOL 100 relative to the eye anatomy.However, the anterior optic 145 can be positioned posteriorly and thestatic element 150 positioned anteriorly relative to the eye anatomy.

The equator region 108 of the annular element 104 of the lens body 105can include at least one shape deformation membrane 140 (best shown inFIGS. 2E-2F). The inner surfaces of the anterior optic 145, the dynamicmembrane 143, the perimeter region 144 of the anterior optic 145, theshape deformation membrane 140 and the static element 150 cancollectively form the fixed volume, sealed chamber 155 filled by thefixed volume of optical fluid 156. The shape deformation membrane 140 ispositioned adjacent the at least one force translation arm 115. As willbe described in more detail below, movements of the force translationarms 115 cause movements of the shape deformation membrane 140 therebydeforming the optical fluid 156 and the sealed chamber 155 to cause achange in the shape of the dynamic membrane 143 of the lens body 105.

The anterior optic 145 can be a flexible optic formed of an opticallyclear, low modulus polymeric material such as silicone, polyurethane, orflexible acrylic. As mentioned above, the anterior optic 145 can includea perimeter region 144 surrounding a central, dynamic membrane 143configured to outwardly bow. The dynamic membrane 143 can be positionedrelative to the lens body 105 such that the optical axis A of the lensextends through the dynamic membrane 143. The perimeter region 144 ofthe anterior optic 145 surrounding the dynamic membrane 143 can becoupled to or integral with the annular element 104 of the lens body105. In some implementations, the perimeter region 144 of the anterioroptic 145 can be coupled to or integral with the anterior end region ofthe annular element 104 (see FIG. 3C). The anterior optic 145 can have aconstant thickness such that it is a planar element. Alternatively, theanterior optic 145 can have a variable thickness. For example, thedynamic membrane 143 can have a reduced thickness compared to theperimeter region 144. The thinner cross-sectional thickness of thedynamic membrane 143 compared to the cross-sectional thickness of theperimeter region 144 can render it relatively more prone to give wayupon application of a force on its inner surface. For example, upon anincreased force applied against inner surfaces of the anterior optic 145during deformation of the sealed chamber 155, the dynamic membrane 143can bow outward along the optical axis A of the lens 100 while theperimeter region 144 maintains its shape. The dynamic membrane 143 canbe configured to give way due to pressure applied by the optical fluid156 within the sealed chamber 155 onto the internal surface of theanterior optic 145 causing an outward bowing of the outer face (e.g.,anterior face). Outer perimeter region 144 of the anterior optic 145 canhave a thickness greater than the inner dynamic membrane 143 of theoptic 145 and can be more resistant to reshaping under such internalpressure applied by the optical fluid 156 in the sealed chamber 155. Theouter perimeter region 144 of the anterior optic 145 can providedistance vision correction even when the inner dynamic membrane 143 isreshaped for near vision. The dynamic membrane 143 can have asubstantially constant thickness. Alternatively, the dynamic membrane143 can have a variable thickness. For example, the dynamic membrane 143can have a linear gradient thickness, curved gradient thickness, 2, 3 ormore thicknesses with a step including radiused or right angles. Thedynamic membrane 143 can also include multiple materials, for example,materials configured to flex near a center of the dynamic membrane 143and other materials configured to reinforce the optic zone and limitdistortion. Thus, the dynamic membrane 143 of the anterior optic 145 canbe formed of a material that is relatively more susceptible to outwardbowing than the material of outer perimeter region 144. The variousregions of the optic 145 can be injection or compression molded toprovide a relatively seamless and uninterrupted outer face. The materialof the regions can be generally consistent, though the dynamic membrane143 can have different stiffness or elasticity that causes it to bowoutward farther than the perimeter region 144.

The anterior optic 145 can be configured to have varied multifocalcapabilities to provide the wearer of the AIOLs described herein withenhanced vision over a wider range of distances, for example, asdescribed in U.S. Publication No. 2009/0234449, which is incorporated byreference herein in its entirety. The “optic zone” as used hereingenerally refers to a region of the lens body 105 that surrounds theoptical axis A of the lens and is optically clear for vision. The“accommodating zone” as used herein generally refers to a region of thelens body 105 capable of undergoing shape change for focusing (e.g. thedynamic membrane 143). The optic zone is configured to have a correctivepower although the entire optic zone may not have the same correctivepower. For example, the dynamic membrane 143 and the perimeter region144 of the anterior optic may each be positioned within the optic zone.The dynamic membrane 143 may have corrective power whereas the perimeterregion 144 may not have corrective power. Or, for example, the diameterdefined by the dynamic membrane 143 may have an optical power and theperimeter region 144 may have a power that is greater or lesser thanthat of the dynamic membrane 143. The dynamic membrane 143 can be equalto or smaller than the overall optical zone can create a multifocallens. The accommodating zone of the lens body 105 can be equal to orsmaller than the overall optic zone.

As mentioned above and still with respect to FIGS. 2A-2F, the equatorregion 108 of the annular element 104 of the lens body 105 can includeat least one shape deformation membrane 140. The shape deformationmembrane 140 can extend along an arc length of the equator region 108 ofthe annular element 104 between the anterior end region of the annularelement 104 and the posterior end region 107 of the annular element 104.The arc length can be sufficient, either individually or in combinationwith other shape deformation membranes 140, to cause a reactive shapechange in the dynamic membrane 143 upon inward (or outward) movement ofthe deformation membrane 140. Movement of the shape deformation membrane140 in a generally inward direction towards the optical axis A of theAIOL 100 during accommodation can cause outward flexure or bowing of thedynamic membrane 143 without affecting the overall optic zone diameterin any axis. The shape deformation membrane 140 can have a flexibilitysuch that it is moveable and can undergo displacement relative to theannular element 104 of the lens body 105, the static element 150, andthe anterior optic 145. For example, the shape deformation membrane 140can be more flexible than adjacent regions of the annular element 104such that it is selectively moveable relative to the annular element 104and the perimeter region 144 of the anterior optic 145. The shapedeformation membrane 140 can have a resting position. The restingposition of the shape deformation membrane 140 can vary. In someimplementations, the resting position is when the shape deformationmembrane 140 is positioned generally perpendicular to a plane P parallelto the anterior optic 145 such that it has a cross-sectional profilethat is vertically oriented, parallel to the optical axis A (see FIG.2F). The resting position of the shape deformation membrane 140 can alsobe angled relative to the optical axis A of the lens body 105. As shownin FIGS. 13A-13B, the cross-section of the side deformation membrane 140may be angled peripherally at an angle Θ¹ relative to the annularstructure 104. In some implementations, the angle Θ¹ is between 45-89degrees. In some implementations, the Θ¹ is 80-89 degrees.Alternatively, the cross sectional profile of the deformation membrane140 may be a curvilinear structure protruding peripherally from theoptical axis A of the lens body 105 (see FIG. 13C). The peripheralprotruding side deformation membrane 140 may protrude peripherally 0.05mm-0.5 mm. In some implementations, the curvilinear protrusion extends0.1 mm-0.3 mm away from optical axis A of the lens body 105 relative tothe equator region 108 of the annular structure 104. The shape andrelative arrangement of the one or more side deformation membranes 140provides the lens with a low force, low movement, high accommodativefunction, as will be described in more detail below.

The movement of the shape deformation membrane 140 can be a compression,collapse, indentation, stretch, deformation, deflection, displacement,hinging or other type of movement such that it moves in a firstdirection (such as generally toward an optical axis A of the lens body105) upon application of a force on the shape deformation membrane 140.The movement of the shape deformation membrane 140 can be located insideor outside the optic zone. Upon release of the force on the shapedeformation membrane 140, the membrane 140 and/or other components ofthe AIOL 100 (e.g. the optical fluid 156 filling the sealed chamber 155)can have elastic memory such that the shape deformation membrane 140returns towards its resting position. Depending on the coupling of theAIOL 100 within the eye, the shape deformation membrane 140 can also bepulled outward away from the optical axis A of the AIOL 100.

The shape deformation membrane 140 lies adjacent or is coupled to arespective force translation arm 115. In some implementations, as theforce translation arm 115 is moved inwardly toward the optical axis A ofthe AIOL 100 due to ciliary muscle contraction, the force translationarm 115 abuts an outer surface of the shape deformation membrane 140 andapplies a force against the outer surface. Thus, the contact between theshape deformation membrane 140 and the force translation arm 115 can bereversible contact such that upon ciliary muscle contraction the forcetranslation arm 115 is urged against the outer surface abutting themembrane 140 and urging it inwardly. Upon ciliary muscle relaxation, theshape deformation membrane 140 returns to its resting position and theforce translation arm 115 returns to its resting position. Theelastomeric nature of the movable components (i.e. the dynamic membraneand/or the shape deformation membranes) can cause a return of the forcetranslation arms 115 to their resting position. In other implementationsand as best shown in FIG. 2F, the shape deformation membrane 140 iscoupled to or integral with its respective force translation arm 115. Aswith the other implementation, upon ciliary muscle contraction the forcetranslation arm 115 and shape deformation membrane 140 move in concertfrom a resting position to a generally inwardly-displaced positioncausing shape change of the dynamic membrane 143.

The number and arc length of each deformation membrane 140 can vary andcan depend on the overall diameter and thickness of the device, theinternal volume, refractive index of the material, etc. Generally, theannular element 104 provides sufficient rigidity and bulk to the AIOLsuch that it can be handled and manipulated during implantation whilethe deformation membrane(s) 140 are sufficiently flexible to allow theforce translation arms to change the shape of the sealed chamber 155.Depending on the overall diameter and thickness of the AIOL 100, the arclength of the shape deformation membrane 140 can be at least about 2 mmto about 8 mm. In some implementations, the AIOL has a single shapedeformation membrane 140 with an arc length of between about 2 mm toabout 8 mm. The single shape deformation membrane 140 can be designed tomove between about 10 μm and about 100 μm upon application of forces aslow as about 0.1 grams of force (go to achieve at least a 1 D, or 1.5 D,or 2 D, or 2.5 D, or 3 D change in the dynamic membrane 143. In anotherimplementation, the AIOL can have two, opposing shape deformationmembranes 140 each having an arc length that is between about 3 mm andabout 5 mm. The shape deformation membranes 140 can be designed to movebetween about 25 μm and about 100 μm each upon application of about 0.25g force to 1.0 g force achieve at least a 1 D change in the dynamicmembrane 143. This is described in more detail below.

The shape deformation membranes 140 can move or collapse relative to therest of the lens body upon application of a degree of force. Generally,the AIOL is designed such that very low forces are sufficient to causemicron movements to cause sufficient diopter changes and with reliableoptics. The force applied to achieve movement of the dynamic membrane143 of the lens body 105 to effect accommodation can be as low as about0.1 grams of force (go. In some implementations, the force applied canbe between about 0.1 gf to about 5.0 gf or between about 0.25 gf toabout 1.0 gf or between about 1.0 gf to about 1.5 gf. The movements ofthe deformable regions of the lens body 105 (e.g. shape deformationmembrane 140) relative to the central portion of the lens body 105 (e.g.dynamic membrane 143) in response to forces applied to achieveaccommodation can be as small as about 50 μm. The movements of the shapedeformation membrane 140 of the lens body relative to the dynamicmembrane 143 in response to forces applied can be between about 50 μm toabout 500 μm, between about 50 μm to about 100 μm, between about 50 μmto about 150 μm, or between about 100 μm to about 150 μm. The ranges offorces applied (e.g. about 0.1 gf to about 1 gf) that result in theseranges of movement in the shape deformation membrane 140 (e.g. 50 μm-100μm) can provide the devices described herein with an accommodatingcapability that is within a dynamic range of greater than at least ±1 Dand preferably about ±3 diopters (D). In some implementations, the poweris between ±4 D and ±6 D for about 100-150 μm movement. The devicesdescribed herein can have an accommodating range that is at least ±1 Dfor about 100 μm movement of the shape deformation membrane 140 andabout a force of at least 0.25 gf applied to the shape deformationmembrane 140. In other implementations, the devices can have anaccommodating range that is at least ±1 D for about 50 μm movement andat least about 1.0 gf. In other implementations, the devices can have anaccommodating range that is at least ±3 D for about 100 μm movement andat least about 1.0 gf. In other implementations, the devices can have anaccommodating range that is at least ±3 D for about 50 μm movement andat least about 0.1 gf.

The micron movements described herein can be asymmetrical micronmovements (e.g. from one side of the device) or can be symmetricalmicron movements from opposing sides of the device or evenly distributedaround the device relative to the optical axis. Whether the micronmovements are asymmetric or symmetrical, the outward bowing of thedynamic membrane 143 achieved is spherical. The micron movementsdescribed herein also can be a total collective movement of the shapedeformation membranes 140. As such, if the lens 100 includes a singleshape deformation membrane 140, that single membrane is capable ofdesired micron movement (e.g. 50 μm-100 μm) to achieve desired dioptricchange (e.g. at least 1 D to about 3 D change). If the lens 100 includestwo shape deformation membranes 140, the membranes together are capableof the achieving between 50 μm-100 μm movement to achieve the at least 1D dioptric change. The dioptric change achieved by the devices describedherein can be at least about 1 D up to approximately 5 D or 6 D change.In some implementations, the dioptric change can be between 7 D and 10D, for example, for patients having macular degeneration.

As mentioned above and still with respect to FIGS. 2A-2F, the lens body105 can include a static element 150 coupled to the annular element 104.The static element 150 can couple to the posterior end region 107 of theannular element 104 whereas the anterior optic 145 can be coupled to ananterior end region of the annular element 104 such that the staticelement 150 and anterior optic 145 are located opposite one anotheralong the optical axis A of the AIOL 100. The way in which the staticelement 150 couples with the annular element 104 can vary. For example,as shown in FIG. 2E-2F, the static element 150 can have a flat surface151 on a first side, a curved surface 152 on a second, opposite side,and a peripheral connecting ring 153 having a sealing surface 154configured to mate with the posterior end region 107 of the annularelement 104. The static element 150 can be positioned outside the lensbody 105 such that the flat surface 151 forms the inner surface facingthe sealed chamber 155 of the lens body 105 and the curved surface 152is in contact with the fluid of the eye. Alternatively, the staticelement 150 can be positioned inside the lens body 105 such that theflat surface 151 is in contact with the fluid of the eye and the curvedsurface 152 forms the inner surface facing the sealed chamber 155 of thelens body 105. The sealing surface 154 of the peripheral connecting ring153 can connect with the posterior end region 107 of the annular element104 such that the peripheral connecting ring 153 is spaced a distanceaway from the equator region 108 of the annular element 104. Theinternal flat surface 151 of the static element 150 can abut an innersurface of the perimeter region 144 of the anterior optic 145.

The static element 150 can be optically clear and provide supportfunction without affecting the optics of the AIOL 100. As such, thestatic element 150 can have zero power and can form a posterior supportto the lens body 105. The static element 150 can be formed of silicone,urethane, acrylic material, a low modulus elastomer, or combinationsthereof. The static element 150 can be or include a static optic tocorrect to emmetropic state, or can be of an appropriate power for anaphakic patient (usually ±10 D to ±30 D). If the AIOL 100 is being usedin conjunction with a separate capsular IOL (e.g. as a “piggyback”lens), the power can be in the range of about −5 D to about +5 D tocorrect for residual refractive or other optical aberrations in theoptical system of the eye. The static element 150 can be plano-convex,convex-plano, convex-convex, concave-convex or any other combination.The static element 150 (or the lens positioned posteriorly) can be atoric lens, spherical lens, aspheric lens, diffractive lens or anycombination of both, for example, in order to reduce or compensate forany aberrations associated to the flexible lens. The relative refractiveindices of the static element 150 and the fluid surrounding it (whetherthat is the fluid of the eye or optical fluid 156 within the sealedchamber 155) will determine the power of the static element 150 for anygiven shape.

The AIOL 100 can include any of a variety of combinations ofreinforcements and/or supports to provide mechanical stability to theassembled lens 100. For example, the reinforcements may be in theperipheral regions of the anterior lens 145 and/or the static element150. The reinforcements can be either optically clear or opaque. Thereinforcing structures may be formed of a rigid polymer, including butnot limited to silicone, polyurethane, PMMA, PVDF, PDMS, polyamide,polyimide, polypropylene, polycarbonate, etc, or combinations thereof.Other regions of the lens 100 can include one or more reinforcements orsupports as well. In some implementations, the one or more supports canbe positioned external to the sealed chamber 155 such that the supportssurround at least an outside portion of the lens body 105. For example,the external support can be a generally annular element extending arounda perimeter of the lens body 105 and have a central opening throughwhich at least the dynamic membrane 143 of the anterior optic 145 isaligned such that the dynamic membrane 143 is available for outwarddeformation.

In other implementations, the AIOL 100 includes one or more internalsupports 110 located within the AIOL 100, such as within or facing thesealed chamber 155 of the lens body 105 (see FIGS. 3A-3C). The one ormore internal supports 110 can be thickened portions on an interior sideof the outer, perimeter region 144 of the anterior optic 145. The one ormore internal supports 110 can also be separate components coupled tothe AIOL. The one or more internal supports 110 can be coupled to and/orembedded inside the perimeter region 144 of the anterior optic 145. Theinternal supports 110 can act to mechanically isolate the opticalcomponents of the lens body 105 from optical distortion during movementof the moving parts of the AIOL 100, such as the force translation arms115, the shape deformation membrane 140, and the dynamic membrane 143.The internal supports 110 can be formed of a material (or materials)that is harder, thicker and/or more rigid than the shape deformationmembrane 140 or the dynamic membrane 143 of the anterior optic 145 toprevent inadvertent movements of the moving parts of the device.Alternatively, the internal supports 110 may be made of the samematerial as the shape deformation membrane 140 or the dynamic membrane143 of the anterior optic 145 and accomplish the mechanically isolatingfunction due to the geometry of the support structure. The support 110can be formed of a rigid polymer, including but not limited to silicone,polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene,polycarbonate, etc., or combinations thereof. For example, the internalsupport 110 can be a combination of multiple silicones or silicone witha rigid or semi-rigid skeletal insert.

FIGS. 3A-3C illustrate an implementation of the lens body 105 includinga perimeter region 144 having a plurality of internal supports 110 a,110 b, 110 c, 110 d. The internal supports 110 can be relatively planarelements that lie generally parallel to the central, longitudinal planeP of the AIOL 100. An outer region of each support 110 can be positionedadjacent to the equator region 108 of the annular element 104 of thelens body 105 and extend inward towards the dynamic membrane 143 of theanterior optic 145. The outer region of the support 110 can be coupledto or integral with the equator region 108 of the annular element 104 orthe outer region of the support 110 can be spaced away from the equatorregion 108 of the annular element 104. FIG. 3A illustrates animplementation having a support 110 b that is spaced away from theequator region 108 of the annular element 104 near where the deformationmembrane 140 extends along an arc length of the equator region 108. Thisspacing away from the deformation membrane 140 provides tolerance suchthat the deformation membrane 140 does not prematurely abut or contactthe support 110 b during inward accommodative movements. As anotherexample, FIG. 3D shows the outer region of two of the inner supports 110a and 110 c support the lens body 105 along an arc of the outerperimeter region such that they are coupled to, integral with, orotherwise contiguous with the equator region 108 of the annular element104 of the lens body 105. The outer region of the other two innersupports 110 b and 110 d are spaced a distance away from the equatorregion 108 of the annular element 104 of the lens body 105, for example,near where the shape deformation membrane 140 extends along an arclength of the annular element 104. This allows for unhindered inwardmovements of the shape deformation membrane 140 and prevents contactbetween the inner support 110 b, 110 d and the respective shapedeformation membrane 140. Similarly, the inner supports 110 of FIG. 3Gshows the outer region of supports 110 b, 110 d are coupled to,integral, or otherwise contiguous with the equator region 108 of theannular element 104 of the lens body 105 whereas the outer region ofsupports 110 a, 110 c are spaced a distance away from the equator region108 of the annular element 104 of the lens body 105 near where the shapedeformation membrane 140 is located.

The distribution of the internal supports 110 on the perimeter region144 of the anterior optic 145 can ensure the supports 110 do notinterfere with movements of the shape deformation membrane 140. Forexample, FIG. 3E shows the internal supports 110 a, 110 b, and 110 c aredistributed such that their outer regions couple to the annular element104 between where the shape deformation membrane 140 and forcetranslation arms 115 are located. Similarly, the internal supports 110a, 110 b, 110 c, and 110 d of the implementation shown in FIG. 3F aredistributed such that the outer regions couple with the annular element104 in between where the shape deformation membrane 140 and forcetranslation arms 115 are located.

The distribution and spacing of the one or more internal supports 110relative to the shape deformation membrane 140 can minimize theircontact with the moving parts of the lens whether near the perimeterregion of the lens body 105 or the central region of the lens body 105.The shape of the internal supports 110 can also minimize or limitcontact between the internal supports 110 and the shape deformationmembrane 140. For example, as best shown in FIG. 3C, the outer region ofthe supports 110 b, 110 d can be beveled near where the supports coupleto the annular element 104 such that the bevel 111 allow for inwardmovement of the shape deformation membrane 140 while avoiding contactbetween the membrane 140 and the outer perimeter of the supports. Thebevel 111 can be a single bevel having an angle that is between about10-80 degrees. It should be appreciated that the outer region of the oneor more supports need not include a bevel. Contact between the shapedeformation membrane 140 and the one or more internal supports 110 canbe avoided in other ways aside from incorporating a bevel. For example,the one or more supports 110 can be spaced a distance away from theshape deformation membrane 140 (e.g. along the perimeter and/or awayfrom the perimeter) to avoid contact. The internal supports 110 can alsohave a length between the outer regions to their inner regions such thatthey extend a distance towards the center of the lens body providingstability and support, but generally stop short of the central, dynamicmembrane 143 of the anterior optic 145. As such, the internal supports110 distributed around the lens body 105 can aid in creating a centralstep-down in thickness from the outer perimeter region 144 of theanterior optic 145 to the dynamic membrane 143 of the anterior optic145.

As mentioned, the overall shape of each of the one or more supports 110can vary. The internal supports 110 can have any of a variety of shapesincluding, but not limited to polygonal, pyramidal, triangular,rectangular, square, trapezoidal, and any of a variety of curvilinearshapes. In some implementations, the one or more supports 110 can have awider dimension near the perimeter of the lens body 105 and a narrowerdimension near the central, dynamic membrane 143 of the anterior optic145. In other implementations, the one or more supports 110 can beelongate rod shapes. The perimeter region 144 of the anterior optic 145can include a single inner support 110, two, three, four, five, six, ormore separate internal supports 110. Thus, the distribution, size,shape, and number of the internal supports 110 can vary.

The lens body 105 can include a fixed volume, sealed chamber 155 filledcollectively formed by the inner-facing surfaces of the shapedeformation membrane 140, the anterior optic 145, and the static element150 and filled by a fixed volume of an optical fluid 156. Theinner-facing surfaces of the one or more inner supports 110 of theperimeter region 144 and the inner-facing surface of the dynamicmembrane 143 of the anterior optic 145 also form part of the sealedchamber 155. Thus, the distribution, size, shape and number of the oneor more supports 110 impacts the overall shape of the sealed chamber155. Again with respect to FIGS. 3A-3G, the adjacent internal supports110 can be spaced a distance away from one another forming a pluralityof corridors 112 through the sealed chamber 155 between the pillars ofsupport. The pillars of support can be shaped to form corridors 112 thatare relatively narrow as shown in FIG. 3D. These narrower corridors 112can create a sealed chamber 155 having a generally H- or X-shape. Thepillars of support can be shaped to form relatively wider corridors 112such as shown in FIGS. 3E-3G. These wider corridors 112 can create asealed chamber 155 having the general shape of a plus, cross, star,trefoil, quadrafoil, cinquefoil, nephroid, or other shape.

The optical fluid 156 filling the sealed chamber 155 can be anon-compressible optical fluid and the volume of the sealed chamber 155can be substantially identical to the volume of optical fluid 156. Assuch, the optical fluid 156 filling the chamber 155 does not causesignificant outward bowing of either the dynamic membrane 143 or thedeformation membrane 140 in the resting state when no substantialoutside forces are applied to the AIOL 100. In some implementations, thesealed chamber 155 can be slightly overfilled with optical fluid 156such that the dynamic membrane 143 has some outward bowing at rest. Asmall degree of resting outward bowing in the dynamic membrane 143 canreduce optical artifacts in the lens. However, no matter how muchresting outward bowing is present in the dynamic membrane 143, themembrane 143 can still undergo additional outward bowing uponapplication of compressive forces on the shape deformation membrane 140to provide accommodation. The pressure inside the sealed chamber 155 canbe substantially equal to the pressure outside the sealed chamber 155.Because the optical fluid 156 in the sealed chamber 155 isnon-compressible its shape deforms along with the shape of the chamber155. Deformation of the chamber 155 in one location (e.g. micrometerinward movements of the shape deformation membrane 140) causes thenon-compressible optical fluid 156 contained within the fixed-volumesealed chamber 155 to press against the inner-facing surfaces formingthe sealed chamber 155. A reactive deformation of the sealed chamber 155occurs in a second location to create sufficient accommodating change.The dynamic membrane 143 of the anterior optic 145 is configured to bowoutward upon application of a force (e.g. due to relative thicknessand/or elasticity) compared to other parts of the anterior optic 145such as the perimeter region 144. Thus, inward movement of shapedeformation membrane 140 urges the optical fluid 156 to deform alongwith the chamber 155 and press against the inner-facing surface of theanterior optic 145. This results in outward bowing and reshaping of theouter surface of the dynamic membrane 143 to cause the accommodativeportion of the optic zone to become more convex increasing the power ofthe AIOL 100. The internal supports 110 provide sufficient stability tothe lens body 105 so that application of the compressive forces on theshape deformation membrane 140 causes the micrometer movements withminimal distortion of the optics.

The optical fluid 156 contained within the sealed chamber 155 of thelens body 105 remains substantially within the optic zone during rest inboth the unaccommodated, resting state and during accommodation. Theoptical fluid 156 remains within the lens body 105 and can contribute tothe accommodative shape change of the dynamic membrane 143 by deformingin shape along with the deformation of the shape of the sealed chamber155. It should be appreciated that this shape change of the dynamicmembrane 143 can occur without actual flow of the optical fluid 156within the sealed chamber 155, for example, from one part of the chamberto another. Rather, a force being applied on the shape deformationmembrane 140 deforms the sealed chamber 155 in a first region that cancause a reactive deformation of the sealed chamber 155 in at least asecond region. The sealed chamber 155 has a fixed volume and isdeformable. The optical fluid 156 filling the sealed chamber 155 changesshape along with and depending on the shape of the sealed chamber 155.Inward deformation of one or more portions of the chamber 155, forexample, movement of the shape deformation membrane 140 near theperimeter region of the lens body 105, can cause a reactive outwarddeformation of another portion of the chamber 155, for example, outwardbulging of the dynamic membrane 143 of the anterior optic 145, due tothe non-compressible optical fluid 156 inside the sealed chamber 155pressing against its inner surface. The optical fluid 156 need not flowbetween separate chambers of the AIOL, but rather the optical fluid 156can change shape along with the changing shape of the sealed chamber 155to cause the accommodative portion of the optic zone of the anterioroptic 145 to bow outward and increase the power of the AIOL 100. Asdescribed elsewhere herein, very small movements of the forcetranslation arms 115 (or single force translation arm 115 in the case ofan asymmetric mechanism) result in immediate, small movements in theshape deformation membrane 140 to change the shape of the dynamicmembrane 143 and sufficient dioptric change. Whether these very smallmovements are symmetrical due to at least a pair of opposing forcetranslation arms 115 or asymmetrical due to a single force translationarm 115, the outward bowing of the dynamic membrane 143 that is achievedis spherical and symmetrical.

Again with respect to FIGS. 2A-2F, the AIOL 100 can include one or moreforce translation arms 115 configured to move back and forth relative tothe lens body 105 to cause the dioptric changes described elsewhereherein. The AIOLs described herein are particularly suited to harnessthe movements of the ciliary body applied directly onto the forcetranslation arms 115 positioned against the ciliary structures intoshape change of the lens. The force translation arms 115 are configuredto harness and translate forces applied by the ciliary structures intothe shape changes of the movable parts of the lens body 105 describedabove. Each force translation arm 115 can include an outer, contactportion 135 and an inner region 137 operatively coupled to a perimeteror equator region of the lens body 105 (see FIGS. 2E-2F). Inner regions137 of each force translation arm 115 can be positioned in contact withor adjacent the shape deformation membrane 140 such that the forcetranslation arm 115 can move relative to the relaxed, shape deformationmembrane 140. For example, the force translation arm 115 can be spacedaway from the membrane 140 during rest, moved inward duringaccommodation to abut against the membrane 140 urging the membrane 140inward, and then upon release of force during disaccommodation move awayfrom the membrane 140 to release the membrane 140 from the inward,deforming force. As such, the inner region 137 of the force translationarm 115 can come into reversible contact with the shape deformationmembrane 140 depending on whether an accommodating force is applied bythe surrounding eye tissue. Alternatively, the inner region 137 of eachforce translation arm 115 can be physically coupled to or integral withthe outer surface of the shape deformation membrane 140 such that theforce translation arm 115 and the membrane 140 move in concert with oneanother.

In some implementations, the inner region 137 of the force translationarm 115 can have a cross-sectional thickness taken along a plane betweenan anterior surface of the lens body 105 and the posterior surface ofthe lens body 105 that is narrower than a cross-sectional thickness ofthe annular element 104 of the lens body 105 taken along the same plane.This can allow for the inner region 137 of the force translation arm 115to displace the deformation membrane 140 a distance inward between theanterior end region and the posterior end region of the annular element104 without abutting against the annular element 104. Thecross-sectional thickness of the inner region 137 of the forcetranslation arm 110 can also allow for inward movement of the arm 115without making contact with an internal support 110 positioned adjacentthe deformable membrane 140 (see FIG. 2F). It should be appreciatedhowever, that the cross-sectional thickness of the inner region 137 ofthe force translation arm 115 need not be narrower than the annularelement 104. The outer contact portion 135 of the force translation arms115 can, but need not, have a larger cross-sectional thickness than theinner region 137. It should be appreciated, however, that the outercontact portion 135 of the force translation arms 115 can also have thesame cross-sectional thickness as the inner region 137. The outercontact portion 135 can also have rounded or curved contours.

The contact portions 135 of the force translation arms 115 canincorporate features that improve their connection with one or more ofthe ciliary structures without causing damage. Generally, the contactportions 135 avoid piercing or causing trauma to the ciliary structures.In some implementations, the contact portions 135 can interfere with theciliary structures while providing an atraumatic surface to engageadjacent eye tissues such that movement can be transferred withoutcausing trauma to the tissues themselves. The outer contact portion 135can also be molded to have one or more concavities, indentations,grooves, teeth, combs, or other surface features to improve, forexample, contact and/or interdigitation with eye tissues such as theciliary process or zonular process.

In some implementations, the outer contact portion 135 can include oneor more concavities 136. The concavities 136 can have a contour thatmatches a contour of a region of the eye with which the contact portion135 associates. For example, upon implantation of the AIOL 100, theouter contact portion 135 of the force translation arms 115 can remainexternal to the capsular bag 22 such that the contact portion 135 canabut, contact, engage, functionally couple to or be in close associationwith one or more ciliary structures during accommodation anddisaccommodation. The concavity 136 in the contact portion 135 can besized to receive one or more portions of these eye tissues. For example,as shown in FIG. 5A, the concavity 136 can engage with the generallyconvex anatomy of the ciliary processes of the ciliary muscle 18. Theconvex anatomy of the eye can rest within the concavity 136 of the outercontact portion 135 providing for better fixation of the AIOL 100 withinthe ciliary sulcus of the eye. The concavity 136 can be centered andsymmetrical within the outer contact portion 135 such that it createsupper and lower lips 134 on either side of the concavity 136 having thesame length. Alternatively, the concavity 136 can be somewhat asymmetricsuch that it creates a slightly longer upper lip 134 compared to theslightly shorter lower lip 134 (see FIG. 3B). In some implementations,the upper lip 134 can have a length sufficient to extend within aportion of the ciliary sulcus when the ciliary process is received bythe concavity 136. The lower lip 134 can also be longer than the upperlip 134. The outer surface of the contact portion 135 can also have asharpened or beveled edges on an upper and/or lower edge such that thecontact portion 135 has generally an S-shape in cross-section. The outercontact portion 135 can also include more than a single concavity 136creating a plurality of smaller grooves in the surface of the outercontact portion 135 providing a surface texture and improve the frictionbetween the force translation arm 115 and the surrounding anatomy.

In some implementations, the outer contact portion 135 can additionallyinclude a plurality of prongs 138 extending posteriorly from the lowerlip 134 of the force translation arm 115 (see FIG. 7D). The prongs 138can have any of a variety of shapes such as conical, wedge, spear, hook,or other shape such that the prongs 138 can extend between the zonulesand/or the ciliary processes. The prongs 138 can, but need not be sharp.In some implementations, the prongs 138 can terminate at an atraumaticend such that they do not damage or tear eye tissues. The prongs 138 canbe flexible such that they are more easily positionable between thezonules or processes. In other implementations, the prongs 138 arerelatively rigid. The prongs 138 can have a length sufficient to extendat least a distance between adjacent zonules and/or processes in orderto provide fixation of the force translation arms 115 within the eye.

The outer portion 135 can have an overall shape such that it extendsalong an arc length configured to engage with a corresponding arc lengthof the annular ciliary structures (see FIG. 3A). The arc length of theouter portion 135 can be longer than the arc length of the inner region137 such that the force translation arms 115 take on a flared shape. Thearc length of the outer portion 135 can also be generally the same orslightly shorter than the arc length of the inner region 137 such thatthe force translation arms 115 take on a rectangular shape or taperedshape, respectively. In some implementations, the force translation arms115 can be wider such that they have a longer arc length. A wider arm115 can displace more material than a narrower force translation arm 115even with small (micro-range) inward movements by the arm 115. A forcetranslation arm 115 that extends along a greater circumference of thelens body (i.e. have a longer arc length) can be made thinner from ananterior-to-posterior direction and still result in the same amount ofdisplacement with each movement as an arm that extends along a shorterarc length and as a greater thickness in an anterior-to-posteriordirection. A thinner force translation arm 115 has an advantage over thethicker arm in that it can be more easily folded or urged into a “taco”shape for implantation through smaller openings. Each force translationarm 115 can include a region configured to provide sufficientaccommodation upon inward movement as well as cross-sectional dimensionto encourage folding or bending of the arms 115 and thus the AIOL 100.For example, in some implementations, each arm 115 can have a centralregion 116 that has a thinner cross-sectional dimension in ananterior-to-posterior direction compared to a cross-sectional dimensionon either side of the central region 116 (see FIGS. 18A-18B). Thisallows for the force translation arms 115 and thus, the AIOL 100 to befolded down the center along a central axis A extending through thesecentral regions 116.

In some implementations, the force translation arm 115 is a unitaryelement having an inner portion 137 and an outer portion 135. The outerportion 135 also can be a separate element capped onto a peripheral endof the force translation arm 115 such that the force translation arm 115is formed of two components coupled together. FIG. 14F illustrates animplementation in which the outer portion 135 is formed of a separateelement capping the inner portion 137. The outer portion 135 can bemanufactured to have a customized length suitable for a particularpatient. For example, the lens body 105 and inner portion 137 of theforce translation arms 115 can be manufactured as a standard sizecomponent and the outer portion 135 can be manufactured separately tohave a thickness and/or length sized according to measurements taken ofa patient. Thus, coupling the customized outer portion 135 onto theinner portion 137 provides an overall diameter of the lens 100 that issized for the diameter of a specific patient. Further, the outer portion135 can be formed of a material that is significantly softer than thematerial of the inner portion 137 such that the outer portion 135provides a softer contact surface for abutting against delicate eyetissues outside the capsular bag as described elsewhere herein.

It should be appreciated that the various components and featuresdescribed herein can be incorporated into the AIOL 100 in any of anumber of combinations. As such, description of a particular featureshown with respect to a particular drawing is not intended to belimiting in that the feature can be incorporated into anotherimplementation of an AIOL 100 described herein. For example, the outerportion 135 that can be a separate component from the inner portion 137in order to provide customization of length and fit can, but need notinclude any of the various features described for the outer portion 135including, but not limited to prongs, grooves, concavities and the like.

The AIOL 100 can be implanted such that the contact portion 135 of theforce translation arms 115 is either in resting contact or readily incontact upon contraction of the ciliary muscle 18 with at least one ofthe ciliary structures (i.e. zonules, ciliary processes, ciliary muscle,and/or ciliary body) to drive shape change of the optics duringaccommodation and disaccommodation. In a preferred implementation, theAIOL 100 is implanted such that the contact portion 135 of the forcetranslation arms 115 lies in resting contact or ready contact with theciliary body apex. In another preferred implementation, the AIOL 100 isimplanted such that the contact portion 135 of the force translationarms 115 lies in resting or ready contact with the ciliary body. In someinstances, the AIOL 100 is sized such that it is generally oversizedrelative to the ciliary structures. This can ensure contact between theforce translation arms 115 and the ciliary structure duringaccommodation. In some implementations, the AIOL is oversized by atleast about 0.80 mm, 0.75 mm, 0.70 mm, 0.65 mm, 0.60 mm, 0.55 mm, or0.05 mm to guarantee ciliary contact with the force translation arms115. It should be appreciated that the AIOL need not be oversized and insome circumstances oversizing of the AIOL may be avoided. For example,accurate measurements of the ciliary diameter at the plane of the AIOLmay be relied upon to ensure the fit of the AIOL is suitable andoptimized for a particular patient.

The force translation arms 115 described herein can have a fixed length.The fixed length force translation arms 115 can have a size selectedthat is appropriate for each patient based on pre-operativemeasurements. Alternatively, the length of the force translation arms115 can be adjustable. The adjustment of the force translation arms 115length can be performed prior to, during, or any time after insertion inthe eye. Along with the adjustment of the length of the forcetranslation arms 115, the position of the force translation arms 115relative to the one or more ciliary structures can vary. In someimplementations, the force translation arms 115 can extend generallyparallel to the plane of the AIOL 100 or can be angled relative to theplane of the AIOL 100.

Contraction of the ciliary muscle and inward/anterior movement of one ormore of the ciliary structures towards the optical axis A of the AIOL100 applies a force against the contact portions 135 of the forcetranslation arms 115. The force translation arms 115 are rigid enoughrelative to the deformation membrane 140 to transfer the forces appliedby one or more moving parts of the eye (e.g. one or more ciliarystructures) to cause inward movement of the deformation membrane 140. Insome implementations, the force translation arms 115 can be a rigidpolymer such as silicone, polyurethane, PMMA, PVDF, PDMS, polyamide,polyimide, polypropylene, polycarbonate, etc., or combinations thereof.In some implementations, the force translation arms 115 can be anelement reinforced with a rigid material. For example, the forcetranslation arms 115 can have an inner, rigid element such as siliconeelastomer, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide,polypropylene, polycarbonate, etc. that is covered by a softer materialsuch as silicone elastomer, polyurethane, or flexible acrylic materialsthat are hydrophobic or hydrophilic. In some implementations, the forcetranslation arms 115 can include an inner, rigid element that extendsbetween the outer contact portion 135 to the inner contact portion 137.In other implementations, the inner, rigid element extends only along apartial length of the force translation arms 115 between the outerportion 135 and the inner portion 137. For example, the inner, rigidelement need not extend clear to the outer contact portion 135 where theforce translation arms 115 make contact with the ciliary structures toprovide a softer and atraumatic surface so as not to damage the ciliarystructures. The inner, rigid element also need not extend clear to theinner contact portion 137 such that upon inward movement of the shapedeformation membrane 140 by the force translation arm 115, the inner,rigid element of the force translation arm 115 remains outside the lensbody 105. Generally, the force translation arms 115 are formed of amaterial and/or sized in a manner that they maintain their shape whenforces are applied to them by a ciliary structure and they do notcollapse or deform upon transferring that force to move the shapedeformation membrane 140. As described above, movement of the shapedeformation membrane 140 causes a shape change in the sealed chamber155, which changes the shape of the optical fluid filling the sealedchamber 155. When the optical fluid presses against the inner surfacesof the lens body 105 it causes an outward bowing in the dynamic membrane143 of the anterior optic 145. This outward bowing results in a morespherical or convex lens body 105 shape thereby increasing the power ofthe lens suitable for near vision focus.

The number of force translation arms 115 and shape deformation membrane140 can vary. The AIOL 100 can include two force translation arms 115positioned on opposing sides of the device lying adjacent to two shapedeformation membrane 140, as shown in FIGS. 2A-2F. Alternatively, theAIOL 100 can include a single force translation arm 115 movable in amanner sufficient to change the shape of the dynamic membrane 143 of theanterior optic 145 to achieve a desired dioptric change. The AIOL 100can also include more than two arms, such as three, four, or more forcetranslation arms 115 distributed around the lens body 105. The forcetranslation arms 115 can be distributed in a symmetric manner around theperimeter of the AIOL 100 or in an asymmetric manner. It should beappreciated that the number of force translation arms 115 need not matchthe number of shape deformation membranes 140. For example, the AIOL 100can include a single shape deformation membrane 140 extending along anarc length of the equator region 108 of the annular element 104 and morethan one force translation arms 115 configured to make contact with orcoupled to different regions of the single shape deformation membrane140.

The AIOL 100 can also include a stabilization system 120. Thestabilization system 120 can be configured to maintain alignment of theoptics of the device and resist movement of the device once the deviceis implanted and undergoing shape changes. Unlike the force translationarms 115, the stabilization system 120 does not cause accommodation ofthe AIOL 100. And because the force translation arms 115 are independentfrom the stabilization system 120 and are not necessary to fix, center,stabilize, and/or hold the AIOL 100 in position within the eye, theAIOLs 100 described herein can incorporate a single, asymmetric forcetranslation arm 115 sufficient to provide the dioptric change of thedynamic membrane.

The stabilization system 120 can be coupled to a perimeter region of thedevice 100, for example, bonded, coupled, or molded as part of the lensbody 105 or to an exterior support, if present. In some implementations,the stabilization system 120 can be coupled to a posterior region of thedevice 100 such that it can provide stabilization and engagement with aportion of the capsular bag, such as with the anterior capsule.

The stabilization system 120 can vary. In some implementations, thestabilization system 120 includes one or more of a stabilization haptic,static haptic, ring-like element, a flange element, or other stabilizingfeature. In some implementations, the stabilization system 120 caninclude a ring-like structure 171 having a flange 172 extending outwardfrom a region of the ring-like structure 171, such as the posterior end(see, for example, FIGS. 7A-7C, FIGS. 11A-11L, FIGS. 14A-14H, FIGS.15A-15C, and FIGS. 16A-16F). An anterior end of the ring-like structure171 can be coupled to the peripheral connecting ring 153 of the staticelement 150 such that the flange 172 on its posterior end extendsposterior to the lens body 105. For example, an outer diameter of thering-like structure 171 can be sized to be received within an innerdiameter of the peripheral connecting ring 153 of the static element150. It should be appreciated, however, that other coupling arrangementsbetween the stabilization system 120 and the lens body 105 areconsidered herein. The ring-like structure 171 and flange 172 can becoupled to or integral with other portions of the lens body 105 such asthe annular element 104 or the annular internal support and need not becoupled to the static element 150. Generally, the coupling of thestabilization system 120 to the lens body 105 is such that the flange172 is positioned in a posterior position relative to the lens body 105and to the force translation arms 115 along the optical axis A of thelens 100. Additionally, the stabilization system 120 and its componentssuch as the flange 172 are coupled to the lens body 105 in a manner thatdoes not interfere with movement of the force translation arms 115 andthe shape deformation membrane 140. For example, as shown in FIG. 7A,FIG. 11A, FIG. 14A, FIG. 15A, and FIG. 16A, the stabilization ring 171can include a pair of flanges 172 that extend outward from the peripheryof the lens body 105 between the location of the force translation arms115. In some implementations, the flanges 172 can have an outerelevation, but because they are positioned 90 degrees relative to theforce translation arms 115 that can provide stability withoutinterfering with accommodative movements of the arms 115. Forces appliedto the flange 172 or the ring-like structure 171 do not get transferredby the stabilization system 120 to the lens 100 in a manner that causesdeformation of the sealed chamber 155 or shape change in the dynamicmembrane 143. The flange 172 can be positioned in a posterior positionrelative to the lens body 105 and to the force translation arm 115. Ananterior surface of the flange 172 may also be on the same plane as theforce translation arm 115. The more anterior the flange 172, the greaterthe flange 172 can pull the lens body 105 in a posterior direction.

The stabilization system 120 can further include a ring 173 protrudingfrom its posterior surface. For example, the ring 173 can extend from aposterior surface of the ring-like structure 171 having the flange 172.The ring 173 can have a narrow, generally square edge 176 (see FIG.14I). The ring 173 of the stabilization system 120 can be positionedrelative to the lens 100 such that it can be positioned within thecapsular bag 22. The ring 173 can have an inner diameter that is about 5mm and an outer diameter that is about 6 mm thereby creating anapproximately 1 mm flat posterior surface. The ring 173 can have aheight this is between about 50 μm-about 700 μm. As such, the edge 176of the ring 173 is generally square- or rectangular-shaped. The edge 176of the ring 173 can create a 360 degree surface for contact against theposterior capsule. The edge 176 of the ring 173 can provide a barrier tolens epithelial cell migration towards the central posterior capsulethat contributes to posterior capsule opacification (PCO). The edge 176of the ring 173 can have other shapes besides square, however, the edge176 provides a relatively sharp contact site between the lens 100 andthe posterior capsular to prevent issues with PCO.

It should be appreciated that other portions of the lens 100 such as thelens body 105, the static element 150, or other region of thestabilization system 120 can incorporate a similar edge to engage theposterior capsule in such a way to minimize the risk of PCO.Additionally, a combination of features may be used to promote fluidflow in the capsular bag and around the lens in order to maintain ahealthy capsular environment with limited PCO. For example, thestabilization system 120 may engage the lens equator while the staticelement 150 and lens body 105 engage the anterior and posterior capsuleto prevent the collapsing of the capsular walls. In another embodiment,stabilization system 120 can be configured to engage multiple capsularsurfaces, thereby keeping the capsule open without assistance from otherlens components.

The ring-like structure 171 of the stabilization system 120 can begenerally cylindrical in shape and the flange 172 can have a generallyoval or elliptical outer dimension such that the flange 172 extends outbeyond the outer diameter of the ring-like structure 171 in at least tworegions along the perimeter of the lens body 105. The anterior end ofthe ring-like structure 171 can be coupled to the peripheral connectingring 153 of the static element 150 and the flange 172 can be dimensionedto remain outside the lens body 105 on a posterior end and extends outbeyond the outer diameter of the lens body 105 at the at least tworegions. The at least two regions where the flange 172 extends outbeyond the outer diameter of the lens body 105 can be oriented relativeto the lens body 105 such that the flange 172 provides stabilizationsupport relative to the force translation arms 115. For example, if thelens 100 includes a pair of opposing force translation arms 115, theflange 172 can be arranged relative to the lens body 105 such that theflange 172 extends outward from the lens body 105 between the locationof the opposing force translation arms 115 (see, for example, FIG. 7A,FIGS. 11A-11B, FIGS. 14A-14C, FIGS. 15A-15C, and FIG. 16A). It should beappreciated that the flange 172 can have other shapes besides oval andelliptical. For example, the flange 172 can also be cylindrical and havean outer diameter configured to extend outward beyond the outer diameterof the ring-like structure 171 and the lens body 105 along 360 degrees.Alternatively, the flange 172 can have more than two locations where itextends beyond the outer diameter of the lens body 105 such as three,four, five, or more locations. The ring-like structure 171 and theflange 172 can provide 360 degree support and stabilization to the lens100.

As mentioned above, the ring-like structure 171 can incorporate a pairof flanges 172 that are positioned between or rotated 90 degreesrelative to the location of the force translation arms 115. An outermostedge of the flanges 172 can project anteriorly such that a channel orgroove 174 is formed near an inner region of the flange 172, for examplebetween the posterior surface of the annular element 104 and an anteriorsurface of the flange 172 (see FIGS. 15A-15C and 16A-16B). When thering-like structure 171 is positioned within the capsular bag, thisouter elevation of the flanges 172 can engage with a posterior-facinginternal surface of the capsular bag to help urge the lens 100 in aposterior direction relative to the bag. Additionally, the edge of thecapsularhexis can be received and held within the groove 174. In someimplementations, the edge can be captured between the groove 174 of theflange 172 and a posterior-facing edge of the annular element 104.

As described elsewhere herein, the force translation arms 115 areconfigured to extend outside the capsular bag 22 to engage with ciliarystructures such that the physiological forces from ciliary musclecontraction can cause a change in optical power of the lens in a mannerthat is independent of the capsular mechanism or movement of thecapsular bag 22. The flange 172 extending outward from a posterior endregion 107 of the annular element 104 can remain inside the capsular bag22 while the force translation arms 115 extending generally from theequator region 108 or anterior end region of the annular element 104extend outside the capsular bag 22 to engage with the ciliarystructures. The flange 172 can be arranged to engage theposterior-facing surface of the edge of the capsular bag 22 formed bythe anterior capsulorhexis C to improve the fixation of the lens 100within the eye. The edge of the capsular bag 22 formed by thecapsulorhexis C can be received within a groove 174 formed between theposterior surface of the annular element 104 and an anterior surface ofthe flange 172 (see FIG. 7B and also FIGS. 14D-14G). The capsulorhexis Ccan thus, aid in fixing the lens position.

The flange 172 can have interruptions providing for flexibility duringhandling as well as allow the surgeon to access portions of the lens 100and capsular bag 22 posterior to the flange 172. This may be preferredin case the surgeon needs to clean the capsular bag, removeviscoelastic, adjust the position of the lens, or any other procedure inwhich the surgeon uses a tool to manipulate the environment posterior tothe AIOL. In some implementations, the interruptions can include one ormore apertures 175 extending through a region of the flange 172 (seeFIG. 11A, and also FIGS. 16A, 16D). The interruptions can also includeone or more indentations 178 or grooves or other feature at an outerperimeter of the flange 172 (see FIGS. 14A-14H). The indentations 178can allow for easy insertion into the eye as well as allow forwithdrawal of viscoelastic from inside the capsular bag 22 using acannula or other tool known in the art.

Because the shape deformation membrane 140 is sensitive to small forcesimparted by the ciliary structures via the force translation arms 115,implantation of the posterior end region of the lens 100 within theanterior capsular fragment can result in inadvertent contact between theedge of the capsulorhexis C and the shape deformation membrane 140. Suchcontact can cause power changes with undesirable optical consequences.Thus, the stabilization system 120 can stabilize the lens positionwithin the eye as well as protect the shape deformation membrane 140from coming into contact with the edge of the capsulorhexis C. Generallyupon implantation, a plane of the capsulorhexis C will intersect a planeof the shape deformation membrane 140. At least a portion of thestabilization system 120 can be designed to extend between where theshape deformation membrane 140 and the capsulorhexis C edge intersect.Thus, the portion of the stabilization system 120 providing a surfacefor the capsulorhexis C edge to contact thereby preventing the edge fromcontacting with the shape deformation membrane 140 to cause optical oraccommodative changes in the AIOL 100.

FIG. 12 illustrates an implementation of a stabilization system 120 thatprevents contact between the edge of the capsulorhexis C and the shapedeformation membrane 140. The stabilization system 120 can be positionednear a posterior region of the lens body 105. The stabilization system120 can include a shield 1205 having a protective rim 1210 positioned atits outermost terminus. It should be appreciated that the actual shapeand configuration of the shield 1205 and rim 1210 can vary. The shield1205 can be a generally annular-shaped element configured to bepositioned external the lens body 105. The shield 1205 can couple to anouter perimeter of a posterior side of the lens body 105. The shield1205 can be coupled to or otherwise extend from the peripheralconnecting ring 153 of the static element 150 over the posterior region107 of the annular element 104 and at least a portion of the equatorregion 108 of the annular element 104. Thus, the shield 1205 forms anannular cap of the peripheral region on the posterior-facing surface ofthe lens body 105 as well as at least a portion of the equator region108 of the annular element 104. Because the shape deformation membrane140 extends along an arc length of the equator region 108 of the annularelement, the shield 1205 covers at least a portion of the shapedeformation membrane 140 as well. The protective rim 1210 can extendoutward from a region of the shield 1205 (the region where the shield1205 covers the portion of the shape deformation membrane 140) therebyforming an angle relative to that region of the shield 1205. The regionof the shield 1205 covering the portion of the shape deformationmembrane 140 can align generally parallel with the shape deformationmembrane 140 such that it covers, but avoids contact the shapedeformation membrane 140. The protective rim 1210 can have a width suchthat it extends along a least a length of the underneath surface (orposterior-facing surface) of the force translation arms 115 near itsinner, contact region 137 where it abuts or is coupled to the shapedeformation membrane 140. The protective rim 1210 can extend generallyparallel with the length of the force translation arms 115 along whichit extends such that the protective rim 1210 forms an approximate 90degree angle relative to where it extends outward from the shield 1205.The width of the protective rim 1210 can vary and thus, the length itextends under the force translation arms 115 can vary. Generally, thewidth of the protective rim 1210 along with the shield 1205 from whichit extends is sufficient to engage a portion of the anterior surface ofthe capsular bag 22 such that the edge of the capsulorhexis C sitswithin the region where the protective rim 1210 and the shield 1205meet. This prevents contact between the shape deformation membrane 140and the edge of the capsulorhexis C. It should be appreciated, that thestabilization system 120 can include a combination of the protective rim1210 and one or more flanges 172 as described above. Thus, thestabilization system 120 can have one or more components configured toremain outside the capsular bag 22 (e.g. the protective rim 1210) suchthat the component extends over an edge of the capsulorhexis C and thestabilization system 120 can have one or more components configured toremain inside the capsular bag 22 (e.g. the flange 172 or astabilization haptic) such that the edge of the capsulorhexis C extendsover the component.

In some implementations, the stabilization system 120 includes one ormore stabilization haptics 160 (see, for example, FIGS. 2B-2F, FIGS.17A-17F, FIGS. 19A-19E). The stabilization haptics 160 can be coupled toor integral with the annular element 104 of the lens body 105 away fromthe location of the at least one shape deformation membrane 140 or in amanner that does not interfere with movement of the shape deformationmembrane 140. For example, the AIOL 100 can include two, opposing shapedeformation membranes 140 and the stabilization system 120 canincorporate a pair of stabilization haptics 160 positioned on or coupledto the annular element 104 at a location that is between the two shapedeformation membranes 140. As such, forces applied to the haptics 160 ofthe stabilization system 120 upon implantation are not transferred bythe stabilization system 120 to the AIOL 100 in a manner that causesdeformation of the sealed chamber 155 or shape change in the dynamicmembrane 143. The internal portion 161 of the haptics 160 can be coupledto or integral with the annular element 104 such that the haptics 160extend from the equator region 108 of the annular element 104 betweenthe anterior end region and the posterior end region 107 of the annularelement 104. Alternatively, the internal portion 161 of the haptics 160can be coupled to or integral with a region of the annular element 104located more anteriorly or more posteriorly along the optical axis ofthe AIOL such as shown in FIG. 2C. Alternatively, the haptics 160 can beconnected to or integrated with the static element 150 as describedabove. In some implementations, the haptics 160 are positioned relativeto the lens body 105 such that they extend outward from the lens body105 at a location that is generally more posteriorly oriented than theforce translation arms 115 (see FIG. 2A). In this implementation, theone or more of the stabilization haptics 160 can be positioned andengaged within the capsular bag 22 to maintain the stability of thedevice 100 during motion of the force translation arms 115 to preventand/or limit anterior, posterior, rotational movements of the device. Inother implementations, the haptics 160 are positioned relative to thelens body 105 such that they extend outward from the lens body 105 at alocation that is generally more anteriorly oriented than the forcetranslation arms 115 (see FIGS. 17A and 19C). In this implementation,the one or more stabilization haptics 160 can be positioned and engagedwithin the ciliary sulcus to maintain the stability of the device 100during motion of the force translation arms 115 to prevent and/or limitanterior and rotation movements of the device. In some implementations,each of the stabilization haptics 160 is arranged relative to the forcetranslation arms 115 such that an internal region 161 of the haptic 160is coupled near a first side of a first force translation arm 115 andits terminal end 162 extends around a circumference of the AIOL 100 awayfrom the first side of the first force translation arm 115 towards theother force translation arm 115 (see FIG. 17A). In otherimplementations, each of the stabilization haptics 160 is arrangedrelative to the force translation arms 115 such that an internal region161 is coupled near a first side of a first force translation arm 115and its terminal end 162 extends over the force translation arm 115 fromthe first side towards an opposite site of the same force translationarm 115 (see FIG. 19A). An AIOL 100 having the terminal ends 162positioned such that they extend over the force translation arms 115reduces the width of the AIOL 100 providing for easier insertion andmanipulation of the AIOL 100 into position in the eye. In eitherimplementation, the stabilization haptics 160 can be angled anteriorlyrelative to the plane of the force translation arms 115 such that theirterminal ends 162 can engage the ciliary sulcus when the AIOL 100 ispositioned, at least in part, within the capsular bag. The stabilizationhaptics 160 can then urge the AIOL 100 in a posterior direction furtherinto the capsular bag. Regardless whether the terminal ends 162 of thestabilization haptics 160 extend over or within the same quadrant as theforce translation arms 115 or between the force translation arms 115,the haptics 160 aid in preventing the force translation arms 115 fromcoming into contact with the iris by applying posterior-directingpressure on the AIOL 100.

Each haptic 160 can loop around along a curve such that the haptic 160is configured to engage eye tissue along a greater portion of theiroverall length. The haptics 160 can be coaxial or coplanar with theforce translation arms 115. The haptics 160 can also be positioned alonga different axis than the force translation arms 115, for example,offset from the force translation arms 115 or angulated relative to theforce translation arms 115. In some implementations, the haptics 160 canbe positioned at an angle in the range of 0-20 degrees or other degreeangle relative to the force translation arms 115. Each haptic 160 canangle away from a plane of the AIOL such that a terminal end 162 of eachhaptic 160 sits on a different plane than the internal region 161 of thehaptic 160 near where it couples to the annular element 104. Forexample, FIGS. 2B-2D shows an implementation of an AIOL having twohaptics 160 and two opposing force translation arms 115. The forcetranslation arms 115 in this implementation are coupled generallycentrally relative to the annular element 104 of the lens body 105 suchthat each of the force translation arms 115 between inner contactportion 137 and outer contact portion 135 are disposed generally along acentral plane of the AIOL. Each of the two haptics 160 in thisimplementation is coupled to a region of the annular element 104 betweenthe two force translation arms 115. The internal region 161 of eachhaptic 160 is positioned or coupled to the annular element 104 at alocation that is slightly posterior to the central plane of the annularelement 104 between anterior and posterior surfaces. Each haptic 160curves from the internal region 161 towards the terminal end 162 suchthat the terminal end 162 of each haptic 160 is positioned on a planethat is posterior to a plane of the internal region 161 of the haptic160. This results in the contact portion 135 of the force translationarms 115 arranged more anteriorly compared to the terminal end 162 ofthe haptics 160 such that they can be implanted in different anatomicallocations within the eye. For example, the contact portions 135 of theforce translation arms 115 can be positioned in the eye such that theymake contact with the ciliary body apex 18 or the ciliary sulcus and thehaptics 160 can extend more posteriorly than the force translation arms115, for example, into the capsular bag 22. It should be appreciated,however, that the one or more haptics 160 can be positioned in the sameplane as the force translation arms 115. Alternatively, the haptics 160can be angled anteriorly in an effort to bias the lens in a posteriorposition (see FIGS. 17A-17F and 19C). In order to minimize contact withthe iris, the haptics 160 can be used to hold lens body 105 and forcetranslation arms 115 posterior relative to terminal end 162 which may beplaced in the sulcus or capsular bag.

Any of the stabilization systems described herein can be arranged to becoaxial or coplanar with the force translation arms 115 or positionedalong a different axis than the force translation arms 115 such that thestabilization system 120 is offset from the force translation arms 115or angled relative to them as described above with respect to thehaptics 160. Similarly, the stabilization systems 120 can be angledrelative to the force translation arms 115 such that at least a portionof the stabilization system 120 angles away from a plane of the AIOLsuch that at least a portion of the stabilization system sits on adifferent plane than another portion of the stabilization system.

It should be appreciated that any of the stabilization systems describedherein can be formed from silicone elastomer, polyurethane, PMMA, PVDF,PDMS, polyamide, polyimide, polypropylene, polycarbonate, or flexibleacrylic materials that are hydrophobic or hydrophilic or any combinationof those materials. The stabilization system may have a softer body thatis reinforced with more rigid structures in order to provide itsstabilizing function while maintaining flexibility for insertion andmanipulation.

One or more portions of the stabilization system 120 described hereincan incorporate biting elements to improve fixation within the eye. Insome implementations, the stabilization system 120 includes haptics 160and the biting elements can be positioned near their terminal ends 162to improve fixation of the haptic 160 within the eye. The haptics 160can be any of a variety of haptic designs or combination of hapticdesigns including, but not limited to open-loop, closed-loop,plate-style, plate loop, monoblock-plate style, j-loop, c-loop, modifiedJ-loop, multi-piece, single-piece, angulated, planar, offset, etc.Haptics 160 considered herein can include the Rayner designed haptics(Rayner Intraocular Lenses Ltd, East Sussex, UK), NuLens designedhaptics (NuLens Ltd., Israel), Staar lens designs (Staar Surgical,Monrovia, Calif.), and others. In some implementations, thestabilization system 120 whether including one or more haptics 160 or a360 degree flange 172 can be formed of a biocompatible polymer such assilicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide,polypropylene, polycarbonate, PEEK, etc. or a combination of suchmaterials. The stabilization system 120 can be formed of a material orconfigured to be foldable. In some implementations, the stabilizationsystem 120 is formed of a shape memory material.

The AIOLs described herein have improved mechanical stability,internally and/or externally, that results in a more efficient shapechange. The shape change is more efficient in that it occurs only wheredesired (i.e. at the shape deformation membrane 140 and the dynamicmembrane 143) without causing distortion or bulging elsewhere in thedevice that would take away from the desired shape change. Theefficiency in shape change is due, in part, to the mechanical isolationof the moving parts. As will be described in more detail below, the oneor more internal supports 110 provide enough rigidity to the AIOL 100 tomechanically isolate the moving parts to effectively and efficientlyimplement the shape change without inadvertent bulging or distortion inother parts of the device. The inner-facing region of the AIOLs 100described herein can have reduced angles, rounded edges, and fewer deadzones improving the efficiency of the shape change achieved.

FIGS. 16A-16F and FIGS. 17A-17F illustrate an implementation of an AIOLhaving an internal support 110. The internal support 110 can function tomechanically isolate the optical elements (anterior and posterior) fromstresses imparted by the stabilization system 120 to limit opticaldistortion. As best shown in FIG. 16D and FIG. 17D, the internal support110 can be a ring-like element that defines a central aperture 113. Theaperture 113 can have an inner diameter that is sized to receive atleast a portion of the static lens element 150 therethrough. Asdescribed elsewhere herein, the static element 150 can have a flatsurface 151 on a first side, a curved surface 152 on a second, oppositeside, and a peripheral connecting ring 153 having a sealing surface 154.The perimeter sealing surface 154 of the static element 150 can abut andseal against a posterior-facing, generally planar surface surroundingthe aperture 113 of the internal support 110. The peripheral connectingring 153 of the static element 150 can be engaged by the inner diameterof the central aperture 113. Thus, the static element 150 can be held bythe aperture 113 of the internal support 110 and the curved surface 152available through the aperture toward the posterior side of the AIOL100. The perimeter region 144 of the anterior optic 145 can bepositioned over a planar, anterior-facing surface of the internalsupport 110 surrounding the aperture 113. As such the planar portion ofthe internal support 110 surrounding the aperture 113 is capturedbetween the perimeter region 144 of the anterior optic and the sealingsurface 154 of the static element 150. The internal support 110 can havean outer perimeter that generally matches an outer perimeter of the lensbody 105. The annular element 104 of the lens body 105 is coupled to theouter perimeter of the internal support 110 (see FIGS. 16B and 17B). Theouter perimeter of the internal support 110 can be spaced a distanceinternal to the peripheral membrane 140 such that upon movement of theforce translation arms 115, the peripheral membrane 140 can be urged adistance inward to cause accommodative shape change. Thus, the annularelement 104 can be coupled at a first location on an anterior surface ofthe internal support and the annular element 104 can be coupled at asecond location on a posterior surface of the internal support 110 suchthat the peripheral membrane 140 spans the distance between the firstlocation and the second location (see FIGS. 16C and 17C). The distancebetween the first and second locations is defined by a width ofwedge-shaped features 117 near the outer perimeter. The presence ofthese features 117 limits movement of the force translation arms 115 andreduces the risk of tearing during implantation in the eye such as byinjection. The features 117 can have a generally wedge shape such that athicker portion of the feature 117 is positioned more peripherallyfacing the peripheral membrane 140 and tapers toward the centralaperture 113. An outer facing surface of the features 117 can be concaveor otherwise angled inward to ensure the peripheral membrane 140 avoidscontact with the feature 117 during movement of the force translationarms 115. It should be appreciated that the feature 117 need not bewedge shaped. For example, FIG. 18C and FIG. 19E illustrate otherimplementations of an internal support 110 having features 117 that aremore square or rectangular in cross-section such that they do not tapertoward the central aperture 113.

Generally, the material of the internal support 110 has enough rigidityto mechanically isolate the optical elements, particularly when the AIOL100 is placed under stress imparted by stabilization haptics 160. FIGS.17A-17F illustrate an implementation of an AIOL 100 having an internalsupport 110 configured to mechanically isolate the optical portions ofthe device from stresses imparted by the stabilization haptics 160. Theinternal support 110 is configured to prevent optical distortions of thecentral area even during movement of the stabilization haptics 160 suchthat the stabilization haptics 160 impart no shape change to the opticalportions of the device such as the dynamic membrane 143 or the anterioroptic 143. The strength of the internal support 110 relative to otherportions of the AIOL 100 such as the shape deformation membrane 140 andthe dynamic membrane 143 provides increased durability duringmanipulation and handling of the lens during insertion.

Regardless the configuration, the internal support 110 can limitefficiency-sapping lens movements in regions of the AIOL 100 other thanwhere accommodative movements are desired. The internal support 110functions to focus all ciliary-induced pressure toward the central,dynamic membrane 143. The internal support 110 mechanically isolatesdynamic areas of the AIOL 100 and structurally reinforces non-dynamicareas of the AIOL 100 thereby focusing the shape change only wheredesired for accommodation—the side deformation membrane 140 viamovements of the force translation arm 115 and the dynamic membrane 143from the increased pressure within the fluid-filled chamber 155. Thegeometry and rigidity of the internal support 110 serves to mechanicallyprevent other lens regions from deforming under the increased internalpressure of the fluid-filled capsule. The internal support 110 can beformed of any of a variety of materials or combination of materials thatcan be opaque or clear, but are generally more rigid than the moveableparts of the AIOL 100. In some implementations, each component of theAIOL 100 is formed of the same material, which provides advantages froma manufacturing stand-points. The material of the various components maybe the same (i.e. silicone), but the mechanical properties of thevarious components may be unique depending on what function thecomponent performs for the AIOL (i.e. shape change or force transfer orcentering and stabilization). One component of the AIOL may be morerigid than another component of the AIOL (e.g. the internal support 110compared to the peripheral membrane 140), but both components may be thesame material. The more rigid component may be more rigid due to thatcomponent's geometry and dimensional differences compared to the lessrigid component. As such, the internal support 110 and the membranes140, 143 can be formed of the same silicone material, but because themembranes 140, 143 have a significantly decreased thickness compared tothe internal support 110 the membranes 140, 143 are easily deformed uponapplication of a compressive force whereas the internal support 110 isnot easily deformed. In some implementations, the internal support 110can be a silicone elastomer (e.g. silicone PDMS 70-90 shoreA) and themembranes 140, 143 can be a silicone elastomer (e.g. silicone PDMS 20-50shoreA). Additionally, the internal support 110 can include a geometrythat imparts a higher rigidity and stiffness relative to the membranes140, 143.

The various components and features of the AIOLs described herein can beincorporated in any of a variety of combinations. As such, descriptionof a particular feature shown with respect to a particular drawing isnot intended to be limiting in that the feature can be incorporated intoanother implementation of an AIOL described herein. For example, theAIOLs described herein can include a stabilization system thatincorporates one or more features of the stabilization systems describedherein. Further, the AIOL having the stabilization system features canbe combined with any of a variety of features described with respect tothe force translation arm 115 or the shape deformation membrane 140, forexample.

The AIOLs described herein can achieve an optical power or diopter (D)in a desirable range (e.g. up to approximately 5 D change) due to shapechange of the anterior optic 145 upon application of a small amount offorce (e.g. as little as 0.1-1.0 grams force (gf)) and micrometer rangemovements of the force translation arms 115 (e.g. up to approximately 25μm-100 μm collectively from each side or from a single side). As such,the AIOLs described herein harness small forces and provide reliableoptics with mechanical isolation such that even asymmetric force canachieve a spherical result in the accommodation. The compressible regioncan be the region of the sealed chamber 155 that undergoes deformationupon movement of the deformation membrane 140 to cause the reactiveoutward bowing of the dynamic membrane 143. The compressible region canhave a length L that is the distance the deformation membrane 140 isdisplaced inward, a height H that is the cross-sectional height of thedeformation membrane 140 along the optical axis of the lens, and an ArcLength W that is the cross-sectional length of the shape deformationmembrane 140 perpendicular to the optical axis A of the lens 100.Displacement of the shape deformation membrane 140 results in avolumetric compression V that correlates with the product of L*H*W. Inthe case of an lens 100 having two force transfer arms 115 with twoshape deformation membranes 140, the volume of fluid V compressed byciliary movement of magnitude L would be roughly 2*L*H*W. The actualvolume may be slightly less than this idealized calculation because ofinefficiencies associated with elastic deformation and complexgeometries. The volume of the lens bowing can be described by:

${V = {\begin{matrix}{\pi h} \\6\end{matrix}\left( {{3a^{2}} + h^{2}} \right)}},$

where the lens height (h) can be calculated from Pythagoras equation:(r−h)²+a²=r². Hence: h=r−√(r²−a²). As an example, if the refractiveindex of the optical fluid within the sealed chamber 155 is 1.4 and thediameter of the lens is 3 mm, a 28 μm movement (L) of two, opposingdeformation membranes 140 with Height (H) 0.37 mm and Arc Length (W) 3.0mm creates a sufficient amount of pressure applied by the optical fluidagainst the anterior optic 145 to form a 1 D lens. If the diameter ofthe lens is 3 mm, an 84 μm movement of two deformation membranes 140with Height (H) 0.37 mm and Arc Length (W) 3.0 mm can create asufficient amount of pressure applied by the optical fluid against thedynamic membrane 143 to form a 3 D lens. Additional examples areprovided below in Tables 1 and 2 below. Table 1 illustrates deviceparameters including power change in diopters (D), diameter of thedynamic membrane 143, curvature of outward bowing of the dynamicmembrane 143, and volume of lens bowing or the volume of the opticalfluid occupying the space created within the outward bowing for devicesfilled with 1.382 refractive index (RI) of optical fluid. Table 2illustrates device parameters including power change in diopters (D),diameter of the dynamic membrane 143, curvature of outward bowing of thedynamic membrane 143, and volume of lens bowing or the volume of theoptical fluid occupying the space created within the outward bowing fordevices filled with 1.43 refractive index (RI) of optical fluid. Thecurvature is calculated based on a starting power of 0 D. The curvaturecan be measured directly with a surface profilometer or a white lightinterferometer. The curvature can also be inferred based on a measuredpower change and known refractive indices.

TABLE 1 Power Change Dynamic Diameter Curvature Volume (D) (mm) (mm)(mm³) 3 2.5 15.3 0.125 4 2.5 11.5 0.167 5 2.5 9.2 0.210 3 3.0 15.3 0.2604 3.0 11.5 0.348 5 3.0 9.2 0.436 3 3.5 15.3 0.482 4 3.5 11.5 0.645 5 3.59.2 0.810

TABLE 2 Power Change Dynamic Diameter Curvature Volume (D) (mm) (mm)(mm³) 3 2.5 31.3 0.061 4 2.5 23.5 0.082 5 2.5 18.8 0.102 3 3.0 31.30.127 4 3.0 23.5 0.169 5 3.0 18.8 0.212 3 3.5 31.3 0.235 4 3.5 23.50.314 5 3.5 18.8 0.393

In some implementations, the device has a dynamic optic diameter of 2.5mm and is filled with oil having 1.382 RI. This device can achieve anaccommodation of about 1.4 D with about 20 microns movement uponapplication of about 0.26 gf, about 2.6 D with about 40 microns movementupon application of about 0.58 gf, about 3.5 D with about 60 micronsmovement upon application of about 0.85 gf, about 4.7 D with about 80microns movement upon application of about 1.1 gf, and about 6.3 D withabout 100 microns movement upon application of about 1.4 gf.

The AIOLs 100 described herein have an improved shape change efficiency.This improved efficiency allows for a greatly reduced volume of thesealed chamber 155 (and thus, the optical fluid 156 filling the chamber155) and a much thinner maximal cross-sectional dimension, particularlynear the perimeter region of the AIOL 100. Even with the minimizedcross-sectional dimension at non-optical perimeter regions the effectivedioptric change (e.g. ±3 or ±4 diopters) is comparable to lenses withlarger volumes. In some implementations, the volume of the chamber 155,and thus the optical fluid 156, can be less than about 8.5 mm³ down toabout 2 mm³. In some implementations, the volume can be between 3 mm³ toabout 6 mm³. The small volume can provide sufficient dioptric change inthe range of ±4 diopters upon micron-range displacement of the membrane140 resulting in corresponding displacement of optical fluid 156 in thechamber 155 that is in a range of about 0.2 mm³ to about 0.3 mm³. Thedisplacement of optical fluid 156 achieved depends on the desiredaccommodating range (e.g. 3 or 4 D), the diameter of the shape changemembrane, and the refractive index of the material within the AIOL. Thelens can be designed to achieve such an “accommodated state” with thedesign of the side membranes, limitations of physiological processes,and maximum efficiency mechanics.

The AIOLs described herein can be implanted according to a variety ofsurgical methods known in the art. Depending upon the features andcomponents of the device, they can be implanted using various techniquesor using various implements. The devices described herein can be usedalone or in combination with another intraocular lens or the patient'snatural lens. The power of the lens body as well as the relativeposition of the force translation arms and/or stabilization system canbe adjusted and/or fine-tuned prior to implantation, during implantationor any time after implantation. The devices described herein can beimplanted such that at least a portion of the device is positionedoutside the lens capsule, for example, anterior to the capsule andposterior to the iris. The devices described herein can be implantedsuch that the central portion of the lens body is aligned with theoptical axis of the eye. The force translation arms can be positionedrelative to the one or more ciliary structures such as the ciliary bodyor the apex of the ciliary muscle. The force translation arms can bepositioned such that they abut with the ciliary structure (or veryclosely associated to the ciliary structure without abutting) withoutcausing compression of the lens body including the deformable region ofthe lens body when the ciliary structure is in the resting,unaccommodated state. However, the force translation arms can bepositioned close enough to the ciliary structure such that uponcontraction of the ciliary muscle the lens body undergoes accommodationand upon relaxation of the ciliary muscle the lens body undergoesdisaccommodation and the materials of the lens body rapidly return totheir resting state. The relative position and length of the forcetranslation arms can be adjusted according to the various methodsdescribed above using one or more of the various features for adjustmentdescribed herein. The stabilization system can be positioned within theciliary sulcus, against the ciliary processes or within a portion of thecapsular bag to further stabilize the device within the eye and toprevent the device from vaulting anteriorly toward the iris, thereinminimizing iris touch. The resting power of the lens body can alsoundergo further adjustment and fine-tuning according to the variousmethods described herein and using one or more of the various featuresfor power adjustment described herein.

The dimensions of the components of the devices described herein canvary. In some implementations, the overall optic zone portion of thelens body 105 can have a diameter that is about 2.5 mm, about 3.0 mm,about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, about 5.5 mm,about 6.0 mm, about 6.5 mm, or greater diameter. In someimplementations, the accommodating diameter, or the region of thecentral optic zone that undergoes a shape change (e.g. the dynamicmembrane 143), is 1.0 mm-6.0 mm in diameter. In some implementations,the dynamic membrane 143 is 1.5 mm-3.5 mm in diameter. In someimplementations, the dynamic membrane 143 is 1.7 mm-2.5 mm in diameter.In some implementations, the AIOL 100 can be foldable such that thedevice can be implanted in the eye through an incision smaller than anotherwise non-foldable, rigid AIOL. For example, a device havingflexible or foldable stabilization system 120 can have a first diameterduring implantation that is smaller than the diameter it achieves afterimplantation following unfolding or expansion of the stabilizationsystem 120. In some implementations, the device can include a supportand the support can be made from a flexible material(s) such that thesupport can bend during implantation of the device. In otherimplementations, the device can flex or fold across a part of thedevice. As described above, the AIOL can include one or more internalsupports 110 and the internal supports 110 can be spaced a distance awayfrom one another forming corridors 112 through the sealed chamber 155between the pillars of support resulting in a sealed chamber 155 havingany of a variety of shapes (e.g. H-shape, X-shape or other shape). FIGS.3D-3G show examples of a potential fold lines F₁ F₂ along one or morecorridors 112 of the AIOL. Other fold lines exist. The AIOLs describedherein can be folded along one or more of these corridors 112 such thatthe adjacent internal supports 110 fold on top of one another. Asdescribed above, the force translation arms 115 can include a centralregion 116 that is thinner to encourage folding across these centralregions 116 (see FIGS. 18A-18C). Folding the AIOLs described herein inthis manner or rolling of the flexible AIOL allows for the device to beimplanted through smaller incisions that wouldn't otherwise be possiblewith AIOLs having rigid components such as supports that are notconfigured to fold. In addition to reducing the overall size of incisionneeded for implantation, folding and/or rolling of the AIOLs describedherein allows for use of typical insertion tools or minimally-invasiveimplantation tools. The AIOLs described herein can also have a narrowcross-sectional thickness allowing for insertion into the eye throughsmall incisions. In some implementations, the AIOL 100 can have across-sectional thickness between the anterior and posterior ends thatis approximately 2.5 mm to as thin as about 0.5 mm. In someimplementations, the device has a cross-sectional maximal thickness ofabout 1.3 mm. As will be described in more detail below, the devicesdescribed herein are configured to be implanted through an incision thatis less than about 4 mm. For example, the devices can be insertedthrough a small incision, such as a clear corneal incision that is nogreater than about 3.5 mm.

FIGS. 4A-4C and also FIGS. 5A-5B illustrate an implementation of an AIOL100 implanted within an eye such that a posterior portion of the AIOL100 including the stabilization system 120 and at least a portion of thestatic element 150 are inserted through a capsulorhexis C into ananterior region of the capsular bag 22. An anterior portion of the AIOL100 including the force translation arms 115 and anterior optic 145extend outside of the capsular bag 22. As such, the anterior capsuleaids in orientation of the AIOL 100 relative to the ciliary body apex.The edge of the capsular bag 22 created by the capsulorhexis C canextend over an anterior face of the stabilization system 120 (whetherthe system 120 includes one or more of a stabilization haptic 160,flanges 172, and/or a ring-like structure providing 360 degreestabilization). For example, in some implementations the edge of thecapsular bag 22 can extend over an anterior face of the one or morestabilization haptics 160 and abut the annular element 104 of the lensbody 105 near where the interior region 161 of the stabilization haptic160 couples to the annular element 104. Alternatively, the edge of thecapsular bag 22 can extend over an anterior face of the flange 172 andslide into groove 174 between the anterior surface of the flange 172 andthe posterior surface of the annular element 104. As described above andas shown in FIGS. 15A-15C, and 16A-16F), the anterior surface of theflange 172 can have an anterior-extending outer elevation configured toengage with a posterior-facing internal surface of the capsular bag ofthe anterior capsule. Alternatively, the edge of the capsular bag 22formed by the capsulorhexis C can extend over the flange 172 and under aprotective rim 1210 of the shield 1205 as described above with respectto the stabilization system 120 shown in FIG. 12 . Regardless thestabilization mechanism 120, the edge of the capsular bag created by thecapsulorhexis C can tuck under a posterior face of the force translationelements 115 such that the force translation elements 115 extend outsidethe capsular bag 22 and at least a portion of the stabilization system120 remains inside the capsular bag 22. Implantation of the AIOL 100 inthis over-under manner provides additional stabilizing support to orientthe AIOL 100 with a visual axis of the eye and prevent movement of theAIOL 100 toward the iris 14. Generally, the AIOL described herein canmaintain a clearance from the iris 14 upon implantation that isapproximately 0.05 mm-0.5 mm. The edge of the capsular bag 22 provide agenerally posterior-directed force on the anterior face of thestabilization system 120 pulling the AIOL away from the iris 14. Thisforce is counterbalanced by the generally anterior-directed force due toengagement between the contact portion 135 of the force translation arms115 and the ciliary structures of the eye.

It should be appreciated that the AIOLs described herein need not beimplanted using an over-under configuration. As described elsewhereherein, the stabilization haptics 160 can be positioned within theciliary sulcus and just a posterior portion of the AIOL positionedwithin the capsular bag. Positioning the stabilization haptics 160within the ciliary sulcus can provide a posterior-direction pressure onthe AIOL 100 for further stabilization and to aid in keeping theperimeter portions of the device away from the iris.

Still with respect to FIGS. 5A-5B, the maximum cross-sectional thicknessT of the AIOL 100 can be approximately 2.5 mm or less such that thedevice can be inserted through a clear corneal incision having a lengthof approximately 3.5 mm. In some implementations, the maximumcross-sectional thickness T taken along a plane of the optical axis A ofthe lens is between about 0.5 mm and 1.5 mm thick. In someimplementations, the maximum cross-sectional thickness T of the AIOLtaken along a plane of the optical axis A of the lens is approximately1.3 mm, is implantable through a 3.5 mm clear corneal incision.

The AIOLs described herein rely on direct contact with the ciliarymuscle in order to achieve accommodation. Thus, at least a portion ofthe perimeter region of the AIOLs must be sized to fit in this narrowspace between the capsular bag and the iris. As described elsewhereherein, the AIOLs described herein have a thin maximum cross-sectionaldimension near the perimeter region to provide this direct engagementwithout negatively impacting the iris. Minimizing the cross-sectionaldimension of the perimeter region greatly reduces the internal volume ofthe AIOL. Additionally, the inner-facing surfaces of the sealed chamberhave reduced angles to further improve the efficiency of the AIOL. Theimproved efficiency of the components of the AIOLs, renders them capableof an effective dioptric change (e.g. ±4 diopters) in spite theirsmaller overall cross-sectional dimension and internal volume comparedto an AIOL having a much larger internal volume. The thickness profileof the non-optical perimeter region (i.e. regions of the AIOL 100 lyingoutside the optical region of the lens) can be minimized to avoidcontact with the iris. FIGS. 4A-4B illustrate an implementation of anaccommodating intraocular lens positioned within the capsular bag 22 andshowing relative position of the perimeter region to the iris 14. FIGS.16A-16F and also FIGS. 17A-17F illustrate implementations of an AIOL inwhich the maximum cross-sectional dimension near this perimeter regionis minimized. The thickness of the AIOL 100 near the optical zone in theposterior direction (e.g. the curved surface 152 of the posterior staticelement 150) extends into the capsular bag 22 and has little to noimpact on the iris 14. As best shown in FIGS. 16E and 17E, the maximumcross-sectional thickness T of the perimeter region of the AOIL 100(i.e. excluding the posterior static element 150 projecting posteriorlyinto the capsular bag) can be between about 500 um to about 700 um. Asbest shown in FIGS. 16F and 17F, the maximum cross-sectional thicknessT′ of the perimeter region of the AOIL 100 (i.e. excluding the posteriorstatic element 150 projecting posteriorly into the capsular bag) can bebetween about 700 um to about 950 um.

The AIOL can be folded or rolled up into an applicator having a 2.5 mmtip although it should be appreciated that other applicators areconsidered herein. Generally, large scleral incisions are to be avoided,however, the AIOLs described herein can be implanted through a scleraltunnel or a scleral incision between about 6 mm and 7 mm long.

In some implementations, as described above, the AIOL is implanted in anover-under manner. The over-under manner of implantation stabilizes thelens position and limits iris touching as described above. Theover-under implantation also prevents inadvertent rotation of the AIOL100 around the optical axis A of the device. Rotation of the AIOL 100around the optical axis A can result in a horizontally-oriented forcetranslation arm 100 moving toward a vertical orientation that is moreprone to shifting away from the ciliary structures that can impair theaccommodating mechanism of the AIOL. As an example, the AIOL 100 caninclude two, opposing force translation arms 115 and can be implantedsuch that the contact portion 135 of each force translation arm 115 iseither in resting contact or readily in contact upon contraction of theciliary muscle 18 (e.g. ciliary body apex) to drive shape change of theoptics during accommodation and disaccommodation. As mentioned above,the AIOL can (but need not) be oversized, for example, by 0.05 mm-0.5mm. The oversizing can be used to ensure contact between the ciliarystructures and the force translation arms. However, in certaincircumstances the oversizing may not be sufficient to ensure contact dueto shifting and settling of the lens or post-operative changes in theciliary body diameter. For example, the AIOL can be oriented such that agap of approximately 0.05 mm may exist between the ciliary structure andthe contact portion 135 of the force translation element 115 on a firstside and another 0.05 mm gap between the contact portion 135 of theforce translation element 115 on a second side and the ciliarystructure. When optimally centered, the gaps remain substantially equalon each side. If the AIOL is implanted such that the opposing forcetranslation elements 115 are oriented vertically relative to the eye(and to each other), the AIOL 100 can settle or shift downward due togravity such that the gap on the superior or cephalad side increases toapproximately 0.1 mm and the gap on the inferior or caudal sidedecreases towards 0 and remains in resting contact against the ciliarystructure. Implantation of the AIOL 100 such that the opposing forcetranslation arms 115 are oriented horizontally (medio-laterally)relative to the eye (and to each other) minimizes the shifting of theAIOL 100 and the optimal spacing between the force translation arms 115and the ciliary structures is maintained during use. Implantation of thestabilization haptics 160 inside the capsular bag 22 and the forcetranslation arms 115 outside the capsular bag 22 limits rotation of theAIOL 100 around the optical axis A and avoids de-centering of thedevice, which can render inoperable the accommodation mechanism of thelens. The orientation of the AIOL in the eye in combination with anoversizing of greater than 0.05 mm-0.5 mm can enhance centering andensure contact with the eye structures. It should be appreciated thatoversizing is not necessary for proper placement and fit of the AIOLsdescribed herein. For example, the patient's ciliary diameter at theplane of the AIOL can be accurately imaged and measured to avoid theneed for oversizing to overcome issues with fit.

The AIOL described herein can be implanted by twisting or rotating intoposition such that the horizontally-oriented force translation arms 115wedge into engagement with the ciliary muscle. This allows foradjustment of the fit during implantation. FIG. 6A is an anterior viewof the eye showing a capsulorhexis. Although not represented in thisfigure, the ciliary muscle 18 naturally has a generally oval shape froman anterior view. The AIOL 100 can be inserted through a small cornealincision through the anterior chamber, past the iris into the posteriorchamber. Once inside the posterior chamber, the AIOL 100 can unfoldand/or unroll. The AIOL can be oriented such that a posterior surface ofthe device is positioned inside (posterior to) the capsulorhexis and theforce translation arms 115 remain outside (anterior to) thecapsulorhexis. The AIOL can be rotated around the optical axis A of thedevice relative to the ciliary muscle until each of the forcetranslation arms 115 wedge into position against the ciliary structure(e.g. the ciliary sulcus or ciliary body apex). The force translationarms 115 wedge into position such that they are generally positioned ina horizontal or mediolateral orientation relative to the eye. The forcetranslation arms 115 can be rotated to wedge into contact with theciliary muscle 18 or can be rotated to maintain a small gap between thecontact portions 135 and the eye tissue. The gap can be, for example, a0.1 mm gap. Once the force translation arms 115 are generally orientedhorizontally relative to the eye, the edges of the capsular bag 22formed by the capsulorhexis C are extended over the anterior surface ofthe stabilization haptics 160. Securing the haptics 120 in the capsularbag 22 in this manner pulls the anterior face of the AIOL 100 away fromthe iris 14. The narrow cross-sectional thickness T of the AIOL alsoprovides a greater clearance relative to the iris 14. In implementationswhere the stabilization haptics 120 are designed to fit within thesulcus, the posterior end region 107 or posterior-most surface of theAIOL can be positioned within the edges of the capsular bag 22 and thestabilization haptics 160 are positioned anteriorly within the sulcus tothereby press the AIOL 100 in a posterior direction.

The capsulorhexis C can be oval shaped and can optionally incorporateone or more slits S extending radially outward from the edge of thecapsulorhexis C and away from the optical axis A of the eye (see FIG.6A). The oval capsulorhexis C and optional slits S allow the AIOL 100 tosink further into the capsular bag 22 and be positioned more posteriorlyby removing or minimizing interference between the anterior capsule andthe posterior surface of the AIOL. This allows the force translationarms 115 to more readily access and wedge against the ciliary body apex18. The anterior capsule can restrict movement of the AIOL whileallowing it to be positioned in a more posterior location. In someimplementations, the oval capsulorhexis C can be 6 mm×7 mm.

Generally, the rotational implantation of the AIOL can allow forachieving optimal positioning between the contact portions 135 of theforce translation arms 115 and the ciliary structures. Rotationalimplantation can avoid the need to adjust the length of the forcetranslation arms 115. However, it should be appreciated that followingimplantation in the eye, the AIOL can be further adjusted to improve fitand/or optical power. For example, the length of the force translationarms 115 can be adjusted as can the angle at which the force translationarms 115 extend away from the lens body 105. One or more portions of thedevice can be expanded or shrunk in situ in order to change the basepower of the lens body 105. In some implementations, the expansionand/or shrinking of the lens body 105 can be performed mechanically suchas by inserting a screw or another mechanical feature against the lensbody 105 to cause a shape change in the lens body 105. In someimplementations, the expansion and/or shrinking of the lens body 105 canbe performed by injecting and/or withdrawing optical fluid 156 fromwithin the sealed chamber 155 of the lens body 105. The amount ofoptical fluid 156 can be changed by injecting and/or withdrawing opticalfluid 156 within the sealed chamber 155 through an external port havinga one-way valve configured to receive a customized syringe needle orpumping mechanism. Tension on the anterior optic 145 (or the staticelement 150) also can be adjusted by applying energy to the material.For example, the material can be a thermal sensitive material that uponthermal activation can create a bleb. Changes in tension and volume onthe lens body 105 can occur depending on whether a bleb, an indentation,or a flattening is formed upon activation of the material. The staticlens can also be modified in this way.

As shown in FIG. 8 , a patient can be assessed pre-operatively bymeasuring the diameter of their ciliary body (box 805). The diameter ofthe ciliary body can be measured by ultrasound biomicroscopy (UBM),optical coherence tomography (OCT), or other medical imaging techniques.The optical power needs of the patient can be measured pre-operatively(box 810). These measurements can be used to select a lens 100 havingoptimal force translation arm 115 dimensions and optical power (box815). As shown in FIG. 9 , following pre-operative measurement of theciliary body diameter (box 905) and selection of a lens having properdimensions and optical power for the patient (box 910), the lens 100 canbe implanted and positioned following cataract removal surgery (box915). Intra-operative assessment(s) of the engagement between thecontact portions 135 of the force translation arms 115 and the targetciliary structure can be performed (box 920). In some implementations,adjustment of the force translation arms 115 can be performed (box 925)and further intra-operative assessment(s) of the engagement performed(arrow 926). The force translation arms 115 can be adjusted for size insitu as described elsewhere herein. Intra-operative assessment of theoptical fit of the lens can be performed until the desired fit isachieved (box 930). In some implementations, the optical power can beadjusted (box 935). The optical power of the lens can be adjusted insitu as described elsewhere herein to create a more spherical orcylindrical lens. Following adjustments, further intra-operativeassessment of the optical fit of the lens can be performed until thedesired power is achieved (arrow 936). The operation can then proceedper standard surgical operations (box 940). FIG. 10 illustrates animplementation of a post-operative lens adjustment similar to the methoddescribed in FIG. 9 . Following pre-operative measurement of the ciliarybody diameter (box 1005) and selection of a lens having properdimensions and optical power for the patient (box 1010), the lens 100can be implanted and positioned following cataract removal surgery (box1015). The operation can proceed per standard surgical operations (box1020). Post-operative assessment(s) of the engagement between thecontact portions 135 of the force translation arms 115 and the targetciliary structure can be performed (box 1025). In some implementations,adjustment of the force translation arms 115 can be performed (box 1030)and further post-operative assessment(s) of the engagement performed(arrow 1036). Post-operative assessment of the optical fit of the lenscan be performed until the desired fit is achieved (box 1035). In someimplementations, the optical power of the lens can be adjusted in situ(box 1040). Following adjustments, further post-operative assessment ofthe optical fit of the lens can be performed until the desired power isachieved (arrow 1046). It should be appreciated that the assessment andadjustment of the lens fit and power, whether performedintra-operatively or post-operatively, can be completely independent ofone another so much so that either can be performed without the other.In certain circumstances, the lens power can be assessed and adjustedwithout the assessment of the lens fit. In other circumstances, the lensfit can be assessed and adjusted without the assessment of the lenspower.

The position of the AIOL can be assessed intra-operatively as well aspost-operatively using imaging techniques known in the art. One or morecomponents of the AIOL may be formed of materials, such as silicone,that is not clearly visible during evaluation using imaging techniquessuch as UBM. Therefore, the AIOL can incorporate one or morevisualization markers 1100 to aid in the assessment of the position ofthe lens. The markers 1100 can be made of a material that is visibleunder one or more types of imaging procedures. In some implementations,the markers 1100 can be formed of polyimide and can be located on or inone or more regions of the lens 100. The material of the visualizationmarkers 1100 can be visually distinct under imaging compared to one ormore components of the remainder of the lens formed, for example, ofanother material such as silicone. The markers 1100 can be integratedinto an internal skeletal structure such as the structures described toreinforce the lens body 105, the force transfer arm 115, the staticelement 150, or stabilization system 120. Alternatively, the markers1100 may not contribute to the function of the lens, but may beadditional components added specifically to enhance visualization.Alternatively, the markers 1100 may be geometric modifications to any ofthe lens components that are easily identifiable with intra-ocularimaging techniques known to the art. For example, a divot or throughhole may be placed in a silicone structure that has an otherwisecontinuous surface. Such markers 1100 can guide a physician in takingmeasurements of the lens 100 to ensure appropriate fit. The highlyvisible markers 1100 can be placed strategically in different areas ofthe lens in a way that illuminates the position of each structurerelative to other lens components and to naturally occurring anatomicalstructures. The markers 1100 may also be useful to visualize dynamicmovement within the lens. For instance, two markers may be positionedsuch that their relative positions depend accommodative state of thelens. Thus, diagnostic imaging of the markers can be used to show thelens transitioning from an accommodative to disaccommodative state.

The visualization markers 1100 can assist the operator in visualizingthe correct plane of the AIOL as well as capture images of the forcetranslation arms 115 along the longest axis. The visualization markers1100 can assist in the capture and analysis of images to clearlyidentify the distance of the force translation arms 115 and the verticalposition of them relative to the ciliary processes. The visualizationmarkers 110 can also aid in analyzing the movement of the forcetranslation arms 115 during accommodation following implantation. FIGS.11A-11L illustrate implementations of a lens 100 incorporating one ormore visualization markers 1100 positioned in various points on the lens100. The visualization markers 1100 can have any of a variety of shapesand sizes to provide additional information related to the orientationand position of the various components of the lens relative to the eyeanatomy. FIGS. 11A-11B illustrate a top plan view and a side elevationalview, respectively, of an implementation of a lens 100 having aplurality of visualization markers 1100. In this implementation, thelens 100 can include first visualization markers 1100 a near the outer,contact region 135 of the force translation arms 115 and secondvisualization markers 1100 b near the inner, contact portion 137 of theforce translation arms 115. A third visualization marker 1100 c can belocated at another location of the lens such as on part of thestabilization system 120 such as on the flange 172 or another portion oflens such as the ring of the posterior element 150. FIGS. 11C-11Dillustrates a top plan view and a side elevational view, respectively,of another implementation of a lens 100 having a plurality ofvisualization markers 1100. The lens 100 can include three sets ofvisualization markers 1100 a, 1100 b, 1100 c. Each of the visualizationmarkers 1100 a, 1100 b, 1100 c can have variable width or thickness suchthat they provide a differentiating cross-sectional view or patternunder imaging depending on where the cross-section is taken. Forexample, the visualization marker 1100 a positioned near the outer,contact region 135 of the force translation arms 115 can have a narrowportion 1105 and a wider portion 1110. Similarly, the secondvisualization marker 1100 b positioned near the inner, contact portion137 of the force translation arms 115 can have a narrow portion 1105 anda wider portion 1110. The third visualization marker 1100 c positionedalong a flange 172 of the stabilization system 120 can also have anarrow portion 1105 and a wider portion 1110. These narrow and wideportions provide patterns of short and long, respectively, when the lensis imaged in cross-section. For example, the cross-sectional image ofthe plurality of visualization markers 1100 a, 1100 b, 1100 c of FIG.11E when taken along line F-F provides a pattern that is“long-short-short” on a first side and “short-short-long” on theopposite side (see FIG. 11F). However, if the cross-sectional image ofthe plurality of visualization marker 1100 a, 1100 b, 1100 c of FIG. 11Gis taken along line H-H, the pattern provided by the markers changes to“short-long-short” and “long-short-short” (see FIG. 11H). Similarly, ifthe cross-sectional image of the plurality of visualization markers 1100a, 1100 b, 1100 c of FIG. 11I is taken along line J-J, the patternprovided changes to “short-short-long” and “long-short-short”. And ifthe cross-sectional image of the plurality of visualization markers 1100a, 1100 b, 1100 c of FIG. 11K is taken along line L-L, the patternprovided changes to “short-long-short” and “short-long-short” and so on.

Suitable materials or combinations of materials for the preparation ofthe various components of the devices disclosed herein are providedthroughout. It should be appreciated that other suitable materials areconsidered. U.S. Patent Publication Nos. 2009/0234449, 2009/0292355 and2012/0253459, which are each incorporated by reference herein in theirentirety, provide further examples of other materials suitable forforming certain components for the devices described herein. One or morecomponents of the lens body 105 can be integral with one another in thatthey are formed of the same material. For example, the internal supports110 can be thickened regions of the perimeter region 144 of the anterioroptic 145. Similarly, the shape deformation membrane 140 and annularelement 104 can be integral with one another having certain physicalproperties, such as a thickness or flexibility, to provide a desiredfunction. Alternatively, one or more of the components of the lens body105 can be coupled together by techniques known in the art. As such, theone or more components of the lens body 105 can be formed of the samematerials or different materials. One or more of the supports 110,perimeter region 144, dynamic membrane 145, and shape deformationmembrane 140 can be formed of an optically clear, low modulus elastomersuch as silicone, urethane, flexible acrylic, or flexible inelastic filmsuch as polyethylene, as well as halogenated elastomers such asfluorosilicone elastomers. The biocompatible optical fluid can be anon-compressible liquid or gel that is clear and transparent in thevisible spectrum, for example, silicone fluids and gels, functionalizedsilicone fluids and gels (for example, halogen, i.e., fluorinatedsilicones, aromatic, i.e., phenyl functionalized silicones, etc.),hydrocarbon and functionalized hydrocarbons, such as long chainhydrocarbons, halogenated hydrocarbons, such as fluorinated andpartially fluorinated hydrocarbons, aqueous systems, both fluids andgels, whose refractive index (RI) has been increased by the additions ofwater-soluble or water swellable polymers, bio-polymer swellableadditives such as cellulose, as well as organic or inorganic additivesthat form nanostructures to increase refractive index. In someimplementations, the optical fluid within the sealed chamber 155 has arefractive index higher than 1.37. In other implementations, the opticalfluid within the sealed chamber 155 has a refractive index between1.37-1.57. In other implementations, the optical fluid within the sealedchamber 155 has a refractive index between 1.37-1.60. In a firstimplementation, the optical fluid filling the sealed chamber 155 is afluorosilicone oil and the components forming the sealed chamber 155(e.g. inner-facing surfaces of the shape deformation membrane 140, thestatic element 150, the inner supports 110, the perimeter region 144 andthe dynamic membrane 143 of the anterior optic 145) are formed of asilicone elastomer. In a second implementation, the optical fluidfilling the sealed chamber 155 is a silicone oil and the componentsforming the sealed chamber 155 are formed of a fluorosilicone elastomer.In a third implementation, the optical fluid filling the sealed chamber155 is an aromatic or phenyl-substituted oil such as phenylsilicone oiland the components forming the sealed chamber 155 are formed of ahalogenated silicone elastomer such as fluorosilicone elastomer. Thecombinations of materials are chosen to optimize stability of the lens,prevent swelling and maintaining optimum refractive index. In someimplementations, the force translation arms 115 can be a rigid polymersuch as silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide,polypropylene, polycarbonate, etc., or combinations thereof. In someimplementations, the force translation arms 115 can be an elementreinforced with PMMA. In some implementations, the AIOL is formed of allsilicone materials including the posterior static element 150 and theforce translation arms 115. The stabilization system 120 can be formedof a more rigid silicone or can be formed of or incorporate polyimide.For example, the stabilization haptics 160 and the flange 172 can bepolyimide.

In various implementations, description is made with reference to thefigures. However, certain implementations may be practiced without oneor more of these specific details, or in combination with other knownmethods and configurations. In the description, numerous specificdetails are set forth, such as specific configurations, dimensions, andprocesses, in order to provide a thorough understanding of theimplementations. In other instances, well-known processes andmanufacturing techniques have not been described in particular detain inorder to not unnecessarily obscure the description. Reference throughoutthis specification to “one embodiment,” “an embodiment,” “oneimplementation, “an implementation,” or the like, means that aparticular feature, structure, configuration, or characteristicdescribed is included in at least one embodiment or implementation.Thus, the appearance of the phrase “one embodiment,” “an embodiment,”“one implementation, “an implementation,” or the like, in various placedthroughout this specification are not necessarily referring to the sameembodiment or implementation. Furthermore, the particular features,structures, configurations, or characteristics may be combined in anysuitable manner in one or more implementations.

The devices and systems described herein can incorporate any of avariety of features. Elements or features of one implementation of adevice and system described herein can be incorporated alternatively orin combination with elements or features of another implementation of adevice and system described herein as well as the various implants andfeatures described in U.S. Patent Publication Nos. 2009/0234449,2009/0292355, 2012/0253459, and PCT Patent Publication No. WO2015/148673, which are each incorporated by reference herein in theirentireties. For the sake of brevity, explicit descriptions of each ofthose combinations may be omitted although the various combinations areto be considered herein. Additionally, the devices and systems describedherein can be positioned in the eye and need not be implantedspecifically as shown in the figures or as described herein. The variousdevices can be implanted, positioned and adjusted etc. according to avariety of different methods and using a variety of different devicesand systems. The various devices can be adjusted before, during as wellas any time after implantation. Provided are some representativedescriptions of how the various devices may be implanted and positioned,however, for the sake of brevity explicit descriptions of each methodwith respect to each implant or system may be omitted.

The use of relative terms throughout the description may denote arelative position or direction or orientation and is not intended to belimiting. For example, “distal” may indicate a first direction away froma reference point. Similarly, “proximal” may indicate a location in asecond direction opposite to the first direction. Use of the terms“front,” “side,” and “back” as well as “anterior,” “posterior,”“caudal,” “cephalad” and the like or used to establish relative framesof reference, and are not intended to limit the use or orientation ofany of the devices described herein in the various implementations.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of what is claimed or of what maybe claimed, but rather as descriptions of features specific toparticular embodiments. Certain features that are described in thisspecification in the context of separate embodiments can also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment canalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination can in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Only a few examples and implementations are disclosed.Variations, modifications and enhancements to the described examples andimplementations and other implementations may be made based on what isdisclosed.

In the descriptions above and in the claims, phrases such as “at leastone of” or “one or more of” may occur followed by a conjunctive list ofelements or features. The term “and/or” may also occur in a list of twoor more elements or features. Unless otherwise implicitly or explicitlycontradicted by the context in which it is used, such a phrase isintended to mean any of the listed elements or features individually orany of the recited elements or features in combination with any of theother recited elements or features. For example, the phrases “at leastone of A and B;” “one or more of A and B;” and “A and/or B” are eachintended to mean “A alone, B alone, or A and B together.” A similarinterpretation is also intended for lists including three or more items.For example, the phrases “at least one of A, B, and C;” “one or more ofA, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, Balone, C alone, A and B together, A and C together, B and C together, orA and B and C together.”

Use of the term “based on,” above and in the claims is intended to mean,“based at least in part on,” such that an unrecited feature or elementis also permissible.

1.-100. (canceled)
 101. A method of implanting lens device for treatmentof an eye, the method comprising: forming a capsulorhexis in a capsularbag of an eye; inserting an intraocular lens device in the eye, thedevice comprising: (i) a lens body having an optical axis, the lens bodycomprising: a first membrane comprising a first perimeter region and acentral, accommodating surface configured to outwardly bow; a shapedeformation membrane extending along an arc of the lens body andconfigured to undergo displacement relative to the first perimeterregion of the first membrane; and a fixed volume of optical fluid,wherein an inner surface of the first membrane, an inner surface of theshape deformation membrane and an inner surface of the static elementcollectively form a sealed chamber of the lens body that contains thefixed volume of optical fluid; (ii) a stabilization system comprising ahaptic having an inner region positioned posteriorly relative to aposterior region of the lens body and an outer region extending radiallyoutward from the inner region, wherein a channel is formed between aposterior-facing surface of the lens body and an anterior-facing surfaceof the inner region; and (iii) a first force translation arm separateand positioned opposite from a second force translation arm, wherein thefirst and second force translation arms are movable relative to the lensbody to cause inward movement of the shape deformation membrane relativeto the first perimeter region of the first membrane causing outwardbowing in an anterior direction of the central, accommodating surface;positioning at least an outermost edge of the haptic of thestabilization system inside the capsular bag of the eye; and positioningeach of the first and second force translation arms outside the capsularbag so an outer region of each of the first and second force translationarms are able to be in direct contact with a ciliary structure of theeye.
 102. The method of claim 101, further comprising extending an edgeof the capsular bag formed by the capsulorhexis over an anterior surfaceof the haptic.
 103. The method of claim 102, wherein the edge of thecapsular bag formed by the capsulorhexis is received within the channelformed between the posterior-facing surface of the lens body and theanterior-facing surface of the inner region.
 104. The method of claim102, wherein an anterior face of the device is pulled away from the irisof the eye by an anterior segment of the capsular bag.
 105. The methodof claim 101, further comprising orienting the device upon implantationsuch that a posterior surface of the device is positioned posterior tothe capsulorhexis and the first and second force translation arms remainanterior to the capsulorhexis.
 106. The method of claim 105, whereinorienting the device comprises orienting the first and second forcetranslation arms horizontally in a medio-lateral manner relative to theeye to minimize shifting following implantation.
 107. The method ofclaim 101, wherein implanting the device further comprises rotating thedevice around the optical axis.
 108. The method of claim 101, furthercomprising rotating the device around the optical axis and maintaining agap between the outer region of each of the first and second forcetranslation arms and the ciliary structure.
 109. The method of claim108, wherein the gap is about 0.1 mm.
 110. The method of claim 101,further comprising rotating the device around the optical axis until theouter region of each of the first and second force translation armswedge into engagement with the ciliary structure, wherein the ciliarystructure is the ciliary muscle of the eye.
 111. The method of claim110, wherein rotating the device adjusts a fit of the first and secondforce translation arms relative to the ciliary muscle.
 112. The methodof claim 101, wherein inserting the device in the eye comprisesinserting the device through a corneal incision in the eye.
 113. Themethod of claim 112, further comprising rolling or folding the deviceinto an applicator sized to insert through the corneal incision. 114.The method of claim 113, wherein a tip of the applicator is about 2.5 mmin cross-sectional diameter.
 115. The method of claim 101, whereininserting the device in the eye comprises inserting the device through ascleral tunnel or a scleral incision.
 116. The method of claim 101,wherein the capsulorhexis is oval shaped.
 117. The method of claim 116,wherein the capsulorhexis is about 6 mm×7 mm.
 118. The method of claim101, further comprising measuring a diameter of the ciliary body of theeye prior to implanting the AIOL device.
 119. The method of claim 118,wherein the diameter is measured by ultrasound biomicroscopy (UBM) oroptical coherence tomography (OCT).
 120. The method of claim 101,wherein the haptic comprises a pair of haptics positioned between thefirst and the second force translation arms, and upon positioning eachof the first and second force translation arms, an edge of the capsularbag formed by the capsulorhexis tucks under a posterior face of thefirst force translation arm, over an anterior face of a first of thepair of haptics, under a posterior face of the second force translationarm, and over an anterior face of a second of the pair of haptics.